Influenza, Human
Conditions
Keywords
Seasonal influenza vaccines, Passive Enhanced Safety surveillance, England, Pilot study
Brief summary
The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse drug reaction (ADR) system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify additional data which may need to be collected in order to appropriately address the requirement.
Interventions
Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
Sponsors
University of Surrey
GlaxoSmithKline
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Volunteers receiving an influenza vaccine and receiving an ADR card at the beginning of the 2016/17 season.
Exclusion criteria
• In the database analysis, registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016). | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR . |
| Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016). | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who receive d the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR . |
| Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR . |
| Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR . |
| Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
| Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. |
| Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. |
| Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. |
| Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. |
| Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. |
| Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Rash AEs include any rash AEs, generalised rash and rash. |
| Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Rash AEs include any rash AEs, generalised rash and rash. |
| Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. |
| Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. |
| Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. |
| Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). |
| Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. |
| Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. |
| Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. |
| Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. |
| Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. |
| Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. |
| Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Rash AEs include any rash AEs, generalised rash and rash. |
| Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Rash AEs include any rash AEs, generalised rash and rash. |
| Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. |
| Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. |
| Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. |
| Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016) | Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. |
Countries
United Kingdom
Participant flow
Pre-assignment details
The study included vaccinated subjects only.
Participants by arm
| Arm | Count |
|---|---|
| Vaccinated_Fluarix Tetra Group Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer practices. | 13,861 |
| Vaccinated_Non GSK Group Volunteered subjects who received Non-GSK influenza vaccination in 10 volunteer practices. | 2,295 |
| Vaccinated_Unknown Group Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in 10 volunteer practices. | 3,178 |
| Total | 19,334 |
Baseline characteristics
| Characteristic | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group | Total |
|---|---|---|---|---|
| Age, Continuous | 66 Years STANDARD_DEVIATION 16.2 | 24 Years STANDARD_DEVIATION 29.7 | 57 Years STANDARD_DEVIATION 24.9 | 60 Years STANDARD_DEVIATION 24.1 |
| Race/Ethnicity, Customized Asian | 327 Participants | 244 Participants | 123 Participants | 694 Participants |
| Race/Ethnicity, Customized Black | 275 Participants | 334 Participants | 133 Participants | 742 Participants |
| Race/Ethnicity, Customized Missing | 3603 Participants | 728 Participants | 1401 Participants | 5732 Participants |
| Race/Ethnicity, Customized Mixed | 39 Participants | 64 Participants | 10 Participants | 113 Participants |
| Race/Ethnicity, Customized Other | 36 Participants | 19 Participants | 5 Participants | 60 Participants |
| Race/Ethnicity, Customized White | 9581 Participants | 906 Participants | 1506 Participants | 11993 Participants |
| Sex: Female, Male Female | 7661 Participants | 1159 Participants | 1808 Participants | 10628 Participants |
| Sex: Female, Male Male | 6200 Participants | 1136 Participants | 1370 Participants | 8706 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1,049 / 13,861 | 62 / 2,295 | 54 / 3,178 |
| serious Total, serious adverse events | 0 / 13,861 | 0 / 2,295 | 0 / 3,178 |
Outcome results
Primary
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 39 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 41 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 42 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 39 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week40 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 41 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 42 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who receive d the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e . cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 35 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 35 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 35 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 38 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 39 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 40 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 42 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 38 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 39 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 40 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 41 | 35 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 42 | 43 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 43 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 44 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 45 | 51 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 46 | 55 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 47 | 55 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 48 | 55 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 48 | 3 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 42 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 43 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 48 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 38 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 39 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 40 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 41 | 37 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 44 | 51 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 45 | 54 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 46 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 47 | 58 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 42 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 39 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 40 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 41 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 42 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 39 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 40 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 41 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 39 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 40 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 41 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 42 | 40 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 43 | 43 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 44 | 45 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 45 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 46 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 47 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 48 | 51 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 39 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 40 | 47 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 41 | 61 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 42 | 72 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 43 | 75 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 44 | 77 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 45 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 46 | 80 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 47 | 80 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 48 | 80 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 39 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 40 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 41 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 42 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 43 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 39 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 40 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 41 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 42 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Decreased appetite, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 38 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 39 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 40 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 42 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Diarrhoea, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 38 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 40 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 39 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 40 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 45 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Vomiting, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nausea, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 38 | 15 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 39 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 40 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 41 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 42 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 43 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 44 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 45 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 46 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 47 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Vomiting, Week 48 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 44 | 61 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 45 | 65 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 46 | 66 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 47 | 66 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 48 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 44 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 73 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 94 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 112 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 118 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 122 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 127 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 130 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 130 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 131 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 39 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 40 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 41 | 36 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 42 | 42 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 43 | 44 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 44 | 45 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 45 | 47 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 46 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 47 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 48 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 38 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 39 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 40 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 43 | 61 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 41 | 35 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 42 | 40 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 43 | 43 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 44 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 45 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 46 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 47 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 48 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 38 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 39 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 40 | 42 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 41 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nausea, Week 42 | 59 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 38 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 39 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 40 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 41 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 42 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 43 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 41 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 48 | 1 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 38 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 39 | 40 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 40 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 41 | 86 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 42 | 103 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 43 | 109 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 44 | 113 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 45 | 118 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 46 | 121 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 47 | 121 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 48 | 121 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 39 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 40 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 43 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 44 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 45 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 46 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 47 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 48 | 10 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 39 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 40 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 41 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 38 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 39 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 40 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 41 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 42 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 45 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 42 | 104 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 39 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 40 | 38 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 41 | 41 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 42 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 43 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 44 | 52 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 45 | 57 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 46 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 47 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 48 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 38 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 39 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 40 | 72 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 41 | 94 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 43 | 107 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 44 | 111 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 45 | 115 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 46 | 119 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 47 | 121 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 48 | 121 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 38 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 39 | 42 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 40 | 41 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 41 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 42 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 45 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 46 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 39 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 48 | 1 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 38 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 39 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 40 | 101 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 41 | 126 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 42 | 144 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 43 | 147 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 44 | 153 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 45 | 160 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 46 | 165 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 47 | 167 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | At risk: Week 48 | 167 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 39 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 40 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 41 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 42 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 43 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 44 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 45 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 46 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 47 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk: Week 48 | 15 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 45 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 40 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 41 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 45 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 40 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 38 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 39 | 47 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 40 | 43 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 41 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 42 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 46 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 39 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 38 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 39 | 40 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 40 | 35 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 41 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 42 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 46 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Fatigue, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Irritability, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Malaise, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Drowsiness, Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 181 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 182 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 39 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 40 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 41 | 56 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 46 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 47 | 72 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 48 | 72 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 38 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 39 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 40 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 41 | 115 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 42 | 128 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 43 | 131 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 44 | 137 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 46 | 152 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 47 | 153 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 42 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 45 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 46 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 47 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 110 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 135 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 155 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 158 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 164 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 173 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 179 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 42 | 65 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 43 | 66 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 44 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 45 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 45 | 146 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Fatigue, Week 48 | 154 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 39 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 40 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 41 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 43 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 44 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Irritability, Week 48 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Malaise, Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 39 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 40 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 41 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 39 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 40 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 41 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 42 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 39 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 40 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 41 | 39 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 42 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 43 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 44 | 53 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 45 | 56 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 46 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 47 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 48 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 39 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 40 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 41 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 42 | 55 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 43 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 44 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 45 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 46 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 47 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 48 | 68 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 38 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 39 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 40 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 41 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 42 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 43 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 45 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 47 | 114 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 48 | 114 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 38 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 39 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 40 | 54 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 41 | 80 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 42 | 93 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 43 | 99 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 44 | 104 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 45 | 112 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 46 | 114 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 39 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 40 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 42 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 43 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 44 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 45 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 46 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 47 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 48 | 13 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 38 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 39 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 40 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 41 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 42 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 43 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 45 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 41 | 88 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 42 | 103 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 43 | 109 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 45 | 124 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 38 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 39 | 36 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 40 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 44 | 116 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 46 | 127 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 47 | 127 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). | Week 48 | 127 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 38 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 39 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 40 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 41 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 42 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 45 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 38 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 39 | 42 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 40 | 42 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 41 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 42 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 45 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 48 | 1 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 38 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 39 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 40 | 51 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 41 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 42 | 81 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 43 | 86 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 44 | 89 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 45 | 96 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 46 | 99 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 47 | 100 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 48 | 100 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 38 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 39 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 40 | 100 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 41 | 120 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 42 | 135 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 43 | 137 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 44 | 143 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 45 | 149 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 46 | 153 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 47 | 154 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 48 | 155 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 39 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 38 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 39 | 54 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 40 | 61 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 41 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 42 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 43 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 44 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 45 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 46 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 39 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 41 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 38 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 39 | 78 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 40 | 139 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 41 | 168 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 42 | 199 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 43 | 206 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 44 | 215 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 45 | 226 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 46 | 231 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 47 | 232 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 48 | 233 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 39 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 40 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 41 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 42 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 43 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 44 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 45 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 46 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 47 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 48 | 22 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 39 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 38 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 39 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 40 | 64 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 41 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 42 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 43 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 44 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 45 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 46 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 40 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 41 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 42 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 38 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 45 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 39 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 40 | 57 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 41 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 42 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 43 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 46 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Muscle aches/myalgia, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Arthropathy, Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 48 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 38 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 39 | 83 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 87 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 151 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 183 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 216 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 223 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 232 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 245 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 252 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 254 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 255 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 39 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 40 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 41 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 42 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 43 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 44 | 73 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 45 | 78 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 46 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 47 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 40 | 140 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 41 | 170 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 42 | 199 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 43 | 206 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 44 | 213 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 45 | 226 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 46 | 232 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 47 | 234 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 48 | 235 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 39 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 40 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 42 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 43 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 45 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 38 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 39 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 40 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 41 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 42 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 39 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 40 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 41 | 54 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 42 | 62 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 43 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 44 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 45 | 76 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 46 | 77 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 47 | 77 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 48 | 78 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 38 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 39 | 38 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 40 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 41 | 80 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 42 | 87 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 43 | 91 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 44 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 45 | 98 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 46 | 100 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 47 | 100 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 48 | 100 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 38 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 39 | 44 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 40 | 37 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 41 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 42 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 43 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 45 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 39 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 40 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 48 | 1 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 39 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 38 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 39 | 61 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 40 | 98 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 41 | 122 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 42 | 135 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 43 | 145 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 44 | 150 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 45 | 158 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 46 | 161 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 47 | 161 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 48 | 161 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 40 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 41 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 42 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 43 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 44 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 45 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 46 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 47 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 48 | 17 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 38 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 39 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 40 | 42 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 41 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 42 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 43 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 45 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Bell's palsy, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 38 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 39 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 40 | 40 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 41 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 42 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 43 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 45 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Headache, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 39 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 41 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Peripheral tremor, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 44 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 164 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 109 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 134 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 149 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 159 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 174 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 177 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 177 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 178 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Bell's palsy, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Guillain-Barre Syndrome, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 38 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 39 | 65 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 40 | 105 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 41 | 128 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 42 | 141 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 43 | 149 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 44 | 154 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 45 | 163 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 46 | 166 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 47 | 166 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Headache, Week 48 | 167 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 39 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 40 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 41 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 42 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 43 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 44 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 45 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 46 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 47 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Peripheral tremor, Week 48 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Seizure/Febrile convulsions, Week 48 | 1 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 42 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 46 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 47 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 48 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 40 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 41 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 42 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 43 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 44 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 45 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 46 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 47 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 48 | 11 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 40 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 40 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 41 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 43 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 44 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 45 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 46 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 47 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 48 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 48 | 1 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Generalised rash, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 40 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 40 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rash, Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 45 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 40 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 41 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 47 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 48 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Generalised rash, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 43 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 44 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rash, Week 46 | 16 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 39 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 40 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 41 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 42 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 43 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 45 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 38 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 39 | 75 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 40 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 41 | 47 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 42 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 43 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 44 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 45 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 39 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 40 | 65 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 41 | 82 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 42 | 109 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 43 | 118 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 44 | 122 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 45 | 132 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 46 | 134 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 47 | 135 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 48 | 135 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 38 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 39 | 97 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 40 | 160 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 41 | 207 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 42 | 237 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 43 | 250 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 44 | 259 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 45 | 268 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 46 | 271 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 47 | 272 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 48 | 272 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 39 | 100 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 44 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 39 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 40 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 42 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 38 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 39 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 40 | 54 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 41 | 45 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 39 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 45 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 41 | 44 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 42 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 43 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 45 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 39 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 43 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 45 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 46 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 39 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 41 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Conjunctivitis, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 39 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 40 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 41 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 42 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 45 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Coryza, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 41 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 45 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Cough, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 38 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 40 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 41 | 64 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 42 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 41 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Epistaxis, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 39 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 40 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 41 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 42 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hoarseness, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 42 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 43 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 45 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Nasal congestion, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 40 | 38 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 41 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 42 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 43 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Oropharyngeal pain, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 38 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 39 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 40 | 53 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 40 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 41 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 42 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Rhinorrhoea, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Wheezing, Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 43 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 44 | 86 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 47 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 46 | 136 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 47 | 136 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 48 | 136 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 41 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 40 | 37 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 41 | 51 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 42 | 222 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 39 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 45 | 66 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 46 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 130 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 225 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 289 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 347 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 369 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 39 | 90 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 382 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 401 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 406 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 408 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 408 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 39 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 40 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 41 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 42 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 44 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 45 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 46 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 47 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 48 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 39 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 40 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 41 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 42 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 43 | 83 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 45 | 93 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 42 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 43 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 45 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 46 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 47 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 48 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 39 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 42 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 43 | 61 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 44 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 40 | 144 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 46 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Coryza, Week 48 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 47 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 48 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 38 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 39 | 38 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 40 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 41 | 93 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 42 | 118 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 43 | 122 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 44 | 127 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Cough, Week 45 | 133 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 47 | 267 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 48 | 267 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 39 | 41 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 40 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 43 | 216 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 44 | 221 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 45 | 235 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 46 | 239 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 47 | 240 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 48 | 240 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 40 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 41 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 42 | 41 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 43 | 43 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 44 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 45 | 51 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 46 | 53 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 47 | 53 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Wheezing, Week 48 | 53 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 41 | 189 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 43 | 240 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 44 | 247 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 45 | 262 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 46 | 266 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 41 | 100 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 42 | 125 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 43 | 134 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 44 | 139 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 45 | 146 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 46 | 148 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 47 | 150 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 48 | 150 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 38 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 39 | 75 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 40 | 128 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 41 | 172 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 42 | 199 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 38 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 39 | 94 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 40 | 88 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 41 | 62 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 42 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 43 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 44 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 45 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 46 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 39 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 40 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 46 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 38 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 39 | 122 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 40 | 210 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 41 | 272 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 42 | 321 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 43 | 343 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 44 | 355 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 45 | 371 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 46 | 376 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 47 | 377 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 48 | 377 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 39 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 40 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 41 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 42 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 43 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 44 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 45 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 47 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 48 | 31 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | At risk: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. | Not at risk: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 41 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 42 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 45 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 46 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 47 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 48 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 48 | 1 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Anaphylactic reactions, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Facial oedema, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Hypersensitivity reactions, Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 45 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 46 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 47 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 48 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 42 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 43 | 4 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years: Week 48 | 0 Participants |
Primary
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 48 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years: Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 45 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 47 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years: Week 48 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years: Week 47 | 3 Participants |
Primary
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 38 | 62 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 39 | 159 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 40 | 151 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 41 | 102 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 42 | 74 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 43 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 44 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 45 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 46 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At Risk: Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 38 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 39 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 40 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 41 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 42 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk: Week 48 | 1 Participants |
Primary
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 42 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 38 | 62 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 39 | 221 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 40 | 372 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 41 | 474 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 42 | 548 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 43 | 577 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 44 | 605 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 45 | 630 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 46 | 641 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 47 | 643 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk: Week 48 | 644 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 38 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 39 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 40 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 41 | 38 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 43 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 44 | 52 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 45 | 55 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 46 | 57 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 47 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk: Week 48 | 59 Participants |
Primary
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 38 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 39 | 169 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 40 | 164 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 41 | 112 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 42 | 85 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 43 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 44 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 45 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 46 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 48 | 2 Participants |
Primary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 38 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 39 | 45 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 40 | 57 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 41 | 36 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 42 | 38 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 43 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 44 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 45 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 46 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | 18-65 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 38 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 39 | 124 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 40 | 107 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 41 | 76 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 42 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 43 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 44 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 45 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 46 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. | >65 years, Week 48 | 1 Participants |
Primary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e . cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 66 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 123 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 159 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 197 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 207 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 219 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 231 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 236 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 237 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 238 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 170 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 277 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 353 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 399 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 418 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 437 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 453 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 461 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 463 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 464 Participants |
Primary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 40 | 400 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 48 | 703 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 38 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 39 | 236 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 41 | 512 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 42 | 597 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 43 | 626 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 44 | 657 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 45 | 685 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 46 | 698 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). | Week 47 | 701 Participants |
Primary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 40 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 41 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 38 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 39 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. | Week 48 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 107 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 116 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 117 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 52 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 121 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 70 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 83 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 94 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 100 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 14 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 10 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 14 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 16 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 17 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 18 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 18 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 18 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 11 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 9 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 39 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 40 | 53 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 41 | 73 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 42 | 88 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 43 | 101 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 44 | 107 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 45 | 115 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 46 | 126 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 47 | 128 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 48 | 133 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 48 | 25 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 43 | 19 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 45 | 23 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 38 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 42 | 19 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 47 | 24 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 39 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 44 | 21 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 41 | 15 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 40 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 46 | 24 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 40 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 41 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 46 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 42 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 43 | 8 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 44 | 11 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 47 | 14 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 45 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 39 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 48 | 16 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 126 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 101 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 119 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 131 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 137 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 141 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 142 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 142 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 41 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 40 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 39 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 39 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 40 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 42 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 40 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 39 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 34 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 38 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 40 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 41 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 45 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 42 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 9 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Decreased appetite, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Vomiting, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nausea, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Diarrhoea, Week 40 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 48 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 41 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 43 | 65 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 142 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 42 | 62 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 41 | 53 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 39 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 46 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 40 | 45 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 40 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 148 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 39 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 41 | 44 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 42 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 46 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 38 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 43 | 55 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 45 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 44 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 152 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 48 | 64 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 45 | 62 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 84 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 47 | 64 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 46 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 44 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 153 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 48 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 44 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 154 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 45 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 40 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 109 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 39 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 47 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 39 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 43 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 40 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 128 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 48 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 41 | 37 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 47 | 70 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 42 | 43 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 42 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 46 | 70 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 43 | 45 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 137 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 45 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 47 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 44 | 65 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 46 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 47 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Diarrhoea, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Vomiting, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nausea, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Decreased appetite, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 2 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 161 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 65 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 111 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 137 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 157 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 168 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 176 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 181 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 183 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 183 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 19 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 40 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 38 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 39 | 44 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 40 | 39 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 46 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 41 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 45 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 42 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 39 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 40 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 51 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 41 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Fatigue, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Drowsiness, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Malaise, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Irritability, Week 40 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 45 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 182 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 41 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 46 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 40 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 47 | 72 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 39 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 48 | 72 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 192 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 120 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 38 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 48 | 169 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 39 | 64 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 199 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 47 | 168 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 40 | 103 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 48 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 46 | 167 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 41 | 125 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 45 | 160 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 42 | 140 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 201 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 44 | 151 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 43 | 145 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 45 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 202 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 148 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 47 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 48 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 39 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 170 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 47 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 40 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 72 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 46 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 41 | 56 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 45 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 42 | 65 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 175 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 44 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 43 | 66 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 43 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 44 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 42 | 14 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Fatigue, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Drowsiness, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Malaise, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Irritability, Week 40 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 93 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 99 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 104 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 112 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 114 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 114 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 114 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 54 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 80 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 38 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 39 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 40 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 41 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 42 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 43 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 45 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 48 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 38 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 39 | 36 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 40 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 41 | 88 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 42 | 103 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 43 | 109 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 44 | 116 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 45 | 124 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 46 | 127 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 47 | 127 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 48 | 127 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). | Week 48 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 44 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 64 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 72 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 43 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 45 | 290 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 38 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 41 | 208 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 39 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 40 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 41 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 42 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 43 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 44 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 48 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 39 | 93 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 40 | 165 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 42 | 252 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 43 | 260 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 44 | 275 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 46 | 299 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 47 | 300 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 48 | 304 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 45 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 46 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 47 | 27 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 46 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 47 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 39 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 40 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 43 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 41 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 42 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 48 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 44 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 45 | 6 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 45 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 43 | 11 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 38 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 40 | 9 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 46 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 41 | 9 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 44 | 11 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 42 | 11 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 47 | 14 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 39 | 6 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 48 | 14 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 44 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 43 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 42 | 42 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 39 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 75 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 41 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 48 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 40 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 39 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 40 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 46 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 38 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 41 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 42 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 45 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 39 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 40 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 42 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 38 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Muscle aches/myalgia, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Arthropathy, Week 46 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 40 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 137 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 183 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 169 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 180 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 163 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 183 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 107 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 183 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 152 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 19 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 1 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 40 | 44 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 45 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 52 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 43 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 42 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 41 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 38 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 39 | 52 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 39 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 38 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Peripheral tremor, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Guillain-Barre Syndrome, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 41 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Seizure/Febrile convulsions, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 43 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Headache, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Bell's palsy, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 39 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 40 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 41 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 42 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 44 | 188 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 43 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 44 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 45 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 38 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 42 | 168 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 41 | 144 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 46 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 42 | 159 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 43 | 170 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 47 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 48 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 45 | 201 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 43 | 181 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 44 | 176 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 46 | 204 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 45 | 187 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 46 | 190 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 48 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 38 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 39 | 72 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 39 | 74 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 47 | 191 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 40 | 120 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 41 | 151 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 47 | 205 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 48 | 192 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 48 | 206 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 40 | 116 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 38 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 47 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 43 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 46 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 42 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 48 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 48 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 44 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 47 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 43 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 45 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 44 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 46 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 45 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 42 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 41 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 42 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 43 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 44 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 45 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 43 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 44 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 45 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 46 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 47 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 48 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Peripheral tremor, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Seizure / Febrile convulsions, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 46 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 47 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Any, Week 48 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Bell's palsy, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Guillain-Barre Syndrome, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 41 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), | Headache, Week 42 | 3 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Rash AEs include any rash AEs, generalised rash and rash.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Rash AEs include any rash AEs, generalised rash and rash.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 43 | 34 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 39 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 40 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 41 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 42 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 44 | 37 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 45 | 39 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 46 | 42 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 47 | 45 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 48 | 45 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 47 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 46 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 48 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 42 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 45 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 43 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 44 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 47 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | At risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) | Not at risk, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash AEs include any rash AEs, generalised rash and rash.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 39 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 40 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 41 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 40 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rash, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Generalised rash, Week 42 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash AEs include any rash AEs, generalised rash and rash.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 44 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 43 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 41 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 48 | 47 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 48 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 47 | 47 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 43 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 46 | 44 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 45 | 40 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 39 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 47 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 42 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 39 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 41 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 40 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 46 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 48 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 41 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 43 | 35 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 47 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 42 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 40 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 45 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 46 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 45 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 44 | 38 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 44 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 40 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 40 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 43 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 40 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 41 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 42 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 46 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 41 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 42 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 44 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 45 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 46 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 47 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 48 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 43 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 44 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 45 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 47 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 48 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 47 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Any, Week 47 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Rash, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) | Generalised rash, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 114 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 103 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 77 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 56 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 18 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 409 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 146 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 249 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 326 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 382 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 427 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 453 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 465 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 470 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 472 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 34 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 37 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 39 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 41 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 41 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 18 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 16 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 19 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 10 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 14 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 11 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 14 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 11 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 1 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 42 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 45 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 34 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 120 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 111 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 82 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 65 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 38 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 39 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 41 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 39 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 40 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 41 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 45 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 38 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 39 | 43 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 40 | 45 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 41 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 42 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 43 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 44 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 45 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 46 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 41 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 39 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 40 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 41 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 42 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 38 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 39 | 70 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 40 | 57 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 41 | 46 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 42 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 43 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 45 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 46 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 39 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 40 | 39 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 41 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 42 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 43 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 38 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 39 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 40 | 54 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 41 | 45 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 42 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 43 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 45 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 39 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 40 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 41 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 42 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 46 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 44 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 42 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 43 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Epistaxis, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hoarseness, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Rhinorrhoea, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Nasal congestion, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Conjunctivitis, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Wheezing, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Coryza, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Oropharyngeal pain, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Cough, Week 38 | 1 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 39 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 44 | 182 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 43 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 47 | 155 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 34 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 154 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 265 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 347 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 412 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 441 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 461 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 490 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 504 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 511 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 513 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 38 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 39 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 40 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 41 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 42 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 43 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 44 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 45 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 46 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 47 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 48 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 48 | 96 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 40 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 41 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 42 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 43 | 83 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 44 | 86 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 45 | 93 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 46 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 47 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 39 | 42 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 40 | 81 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 41 | 102 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 42 | 127 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 38 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 43 | 137 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 44 | 142 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 45 | 150 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 46 | 152 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 48 | 155 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 38 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 39 | 75 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 40 | 129 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 41 | 174 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 42 | 201 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 43 | 218 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 44 | 223 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 45 | 238 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 46 | 242 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 47 | 243 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 48 | 243 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 39 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 40 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 41 | 36 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 42 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 43 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 44 | 56 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 45 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 46 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 47 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 48 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 39 | 54 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 40 | 99 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 41 | 132 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 42 | 162 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 43 | 170 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 45 | 196 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 46 | 206 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 47 | 209 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 48 | 210 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 40 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 42 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 44 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 45 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 46 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 47 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 48 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 39 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 40 | 37 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 41 | 52 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 42 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 43 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 44 | 65 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 45 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 46 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 47 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 48 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 38 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 39 | 92 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 40 | 149 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 41 | 195 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 42 | 228 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 43 | 247 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 44 | 254 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 45 | 269 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 46 | 274 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 47 | 276 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 48 | 276 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 38 | 9 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 47 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 42 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 43 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 44 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 48 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 39 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 40 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 45 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 41 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 42 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 43 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 44 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 45 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 46 | 15 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 47 | 17 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 48 | 17 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 13 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 17 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 17 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 20 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 22 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 23 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 46 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 43 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 44 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 45 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 46 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 47 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 48 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Rhinorrhoea, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Oropharyngeal pain, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Wheezing, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 38 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Nasal congestion, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 40 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Epistaxis, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 41 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Coryza, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Conjunctivitis, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Cough, Week 42 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hoarseness, Week 48 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | At risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis | Not at risk, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 10 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 40 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 39 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 43 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 48 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 47 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 42 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 46 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 45 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 44 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 41 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Facial oedema, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Hypersensitivity reactions, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Anaphylactic reactions, Week 48 | 0 Participants |
Secondary
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 81 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 105 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 47 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 216 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 203 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 155 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 15 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 10 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 40 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 39 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 41 | 6 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 42 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 43 | 9 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 44 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 45 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 46 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 47 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | Not at risk, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. | At risk, Week 38 | 7 Participants |
Secondary
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 81 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 62 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 70 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 809 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 75 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 80 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 297 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 88 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 856 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 91 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 93 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 905 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 934 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 500 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 945 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 956 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 655 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 760 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 26 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 33 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 42 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 47 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 9 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 37 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 10 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 49 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 11 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 22 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 11 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 50 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 41 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 48 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 38 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 39 | 9 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 40 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 41 | 19 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 42 | 26 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 43 | 35 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 44 | 38 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 45 | 41 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 46 | 43 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 47 | 46 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | At risk, Week 48 | 47 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 42 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 43 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 44 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 45 | 6 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 46 | 6 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). | Not at risk, Week 47 | 6 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 77 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 160 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 140 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 112 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 359 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 232 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 373 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 378 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 384 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 219 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 471 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 538 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 571 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 602 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 629 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 644 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 659 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 172 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 281 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 304 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 325 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 352 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 652 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 21 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 11 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 14 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 21 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 16 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 9 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 15 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 18 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 17 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 18 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 17 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 17 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 23 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 9 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 18 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 17 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 11 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 11 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 15 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 26 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 6 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 14 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 16 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 16 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 18 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 26 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 17 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 18 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 13 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 18 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 23 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 24 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 26 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 26 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 38 | 87 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 39 | 227 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 40 | 218 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 41 | 172 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 42 | 118 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 43 | 57 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 44 | 52 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 45 | 54 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 46 | 37 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 47 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 48 | 13 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 43 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 38 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 42 | 10 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 39 | 10 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 44 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 41 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 40 | 11 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 46 | 6 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 40 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 41 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 46 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 42 | 8 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 43 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 44 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 47 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 38 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 45 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 39 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 48 | 2 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 45 | 985 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 46 | 1022 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 41 | 704 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 39 | 314 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 38 | 87 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 42 | 822 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 48 | 1049 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 47 | 1036 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 43 | 879 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 40 | 532 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 44 | 931 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 40 | 25 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 45 | 52 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 46 | 58 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 39 | 14 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 47 | 60 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 48 | 62 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 44 | 50 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 41 | 30 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 42 | 40 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 38 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 43 | 44 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 48 | 54 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 38 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 39 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 40 | 14 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 41 | 21 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 42 | 29 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 43 | 39 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 44 | 43 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 46 | 49 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 47 | 52 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Week 45 | 47 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 31 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 38 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 43 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 56 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 57 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 41 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 47 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 29 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 56 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 69 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 9 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 11 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 12 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 13 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 39 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 40 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 41 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 42 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 43 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 44 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 45 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 46 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 48 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 38 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 42 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 39 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 41 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 40 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 42 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 43 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 44 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Week 48 | 2 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 53 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 43 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 36 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 92 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 89 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 85 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 73 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 98 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 56 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 34 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 98 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 56 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 97 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 55 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 55 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 44 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 61 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 76 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 109 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 113 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 118 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 129 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 123 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 129 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 127 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 98 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 72 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 9 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 63 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 60 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 55 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 48 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 59 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 56 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 53 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 39 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 68 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 27 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 15 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 33 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 50 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 52 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 190 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 120 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 199 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 121 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 72 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 205 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 123 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 57 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 206 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 114 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 208 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 154 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 121 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 105 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 177 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 100 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 180 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 19 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 8 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 5 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 8 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 8 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 331 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 47 | 307 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 48 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 44 | 276 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 178 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 47 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 40 | 49 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 39 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 46 | 79 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 41 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 43 | 263 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 45 | 78 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 42 | 69 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 43 | 71 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 226 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 44 | 73 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 272 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 48 | 311 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 42 | 255 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 280 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 46 | 305 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 41 | 213 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 295 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 40 | 167 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 313 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 39 | 99 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 325 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 45 | 294 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 38 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 327 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 103 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 46 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 39 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 40 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 41 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 42 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 43 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 44 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 45 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 47 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 48 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 46 | 14 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 38 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 45 | 14 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 46 | 14 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 39 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 44 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 40 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 43 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 41 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 41 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 42 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 47 | 15 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 42 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 40 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 43 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 39 | 7 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 44 | 12 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 38 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 48 | 15 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 48 | 15 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Arthropathy, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Any, Week 47 | 15 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). | Muscle aches/myalgia, Week 45 | 14 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 20 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 22 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 54 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 92 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 34 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 86 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 107 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 84 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 107 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 66 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 40 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 105 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 98 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 97 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 101 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 96 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 95 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 107 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 84 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 96 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 76 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 67 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 4 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 1 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 25 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 21 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 23 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 30 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 14 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 16 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 10 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 13 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 18 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 12 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 11 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 28 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 24 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 36 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 13 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 32 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 17 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 36 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 58 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 75 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 88 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 174 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 165 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 331 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 147 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 140 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 128 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 328 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 100 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 76 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 324 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 313 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 40 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 300 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 283 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 247 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 189 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 114 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 26 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 178 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 333 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 178 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 8 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 3 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 5 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 6 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 7 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 2 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 4 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 3 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 6 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 9 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 10 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 1 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 2 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 1 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. | 6-12 years, Week 48 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 7 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 6 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 9 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 5 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 8 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 4 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 18-65 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6 months - 5 years, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | >65 years, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 6-12 years, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). | 13-17 years, Week 42 | 0 Participants |
Secondary
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Population: The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 48 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 40 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 42 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 45 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 46 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 2 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 43 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 42 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 3 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 41 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 46 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 40 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 47 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 39 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 44 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 38 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 45 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 44 | 1 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 40 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 37 | 0 Participants |
| Vaccinated_Fluarix Tetra Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 48 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 38 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 40 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 41 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 42 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 46 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 43 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 44 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 1 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Non GSK Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 37 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 44 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 42 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 38 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 45 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 41 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 46 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 40 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 43 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Hypersensitivity reactions, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 39 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Anaphylactic reactions, Week 48 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Facial oedema, Week 47 | 0 Participants |
| Vaccinated_Unknown Group | Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. | Any, Week 47 | 0 Participants |