Influenza (Healthy Volunteers)
Conditions
Keywords
Influenza
Brief summary
Primary Objective: Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants. Safety: To describe the safety profile of all participants in each study groups.
Detailed description
The duration of each participant's participation was approximately 28 days (Day 0 through Day 28 \[+ 7 days\]).
Interventions
BIOLOGICALHigh-Dose Quadrivalent Influenza Vaccine
Pharmaceutical form: Suspension for injection in pre-filled syringe, Route of administration: IM
Pharmaceutical form: Suspension for injection in pre-filled syringe, Route of administration: IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study was modified double-blind. The designated vaccine prepare(s)/administrator(s) would be unblinded given that the QIV-HD and QIV-SD vaccines had different dose volumes. Neither the participant nor the investigator nor the study staff in charge of vaccination was aware of which vaccine was administered (the syringes was masked to maintained the blinding of the participants and other members of the clinical site). The unblinded designated vaccine preparer(s)/administrator(s) was not involved in any of the blinded study assessments (eg, immunogenicity, safety).
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * 65 years and older on the day of inclusion. * Able to attend all scheduled visits and complied with all study procedures.
Exclusion criteria
* Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine prior to Visit 2. * Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances. * Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on Investigator's judgment contraindicate intramuscular vaccination. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion. * Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to \[\>=\] 38.0 degree Celsius). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Personal or family history of Guillain-Barré syndrome. * Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and had been disease free for \>=5 years). * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse) of the Investigator or employee with direct involvement in the proposed study. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution. |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | Day 0 (pre-vaccination) | GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria Lineage), and B2 (B Yamagata Lineage). Titers were expressed in terms of 1/dilution. |
| Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). |
| Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | Day 28 (post-vaccination) | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (\>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer \>=10 (1/dilution) at Day 0 and a \>= four-fold increase in post-vaccination titer at Day 28. |
| Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | Day 0 (pre-vaccination) | Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). |
| Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | Day 28 (post-vaccination) | Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). |
| Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Within 30 minutes post-vaccination | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. |
| Number of Participants With Solicited Injection Site and Systemic Reactions | Within 7 days post-vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. |
| Number of Participants With Unsolicited Adverse Events | Within 28 days post-vaccination | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. |
| Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | From Day 0 up to 28 days post-vaccination | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. |
Countries
Taiwan
Participant flow
Recruitment details
The study was conducted at 4 active centers in Taiwan. A total of 165 participants were enrolled and randomized between 10 November 2020 to 12 January 2021.
Pre-assignment details
A total of 165 participants were vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. | 82 |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. | 83 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Total | Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) |
|---|---|---|---|
| Age, Continuous | 71.4 years STANDARD_DEVIATION 5.71 | 71.4 years STANDARD_DEVIATION 5.52 | 71.5 years STANDARD_DEVIATION 5.37 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 83 Participants | 165 Participants | 82 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 46 Participants | 93 Participants | 47 Participants |
| Sex: Female, Male Male | 37 Participants | 72 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 83 |
| other Total, other adverse events | 46 / 82 | 35 / 83 |
| serious Total, serious adverse events | 0 / 82 | 0 / 83 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria Lineage), and B2 (B Yamagata Lineage). Titers were expressed in terms of 1/dilution.
Time frame: Day 0 (pre-vaccination)
Population: Analysis was performed on the full analysis set (FAS) that included randomized participants who received one of the study vaccine and had a post-vaccination blood sample. Participants were analyzed according to the vaccine group to which they were randomized.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | A/H3N2 | 111 titers |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | B1 | 88.0 titers |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | B2 | 149 titers |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | A/H1N1 | 23.6 titers |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | A/H1N1 | 24.1 titers |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | A/H3N2 | 169 titers |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | B2 | 160 titers |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | B1 | 98.2 titers |
Primary
Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.
Time frame: Day 28 (post-vaccination)
Population: Analysis was performed on FAS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | A/H1N1 | 283 titers |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | A/H3N2 | 643 titers |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | B1 | 812 titers |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | B2 | 707 titers |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | B2 | 361 titers |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | A/H1N1 | 109 titers |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | B1 | 324 titers |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | A/H3N2 | 427 titers |
Primary
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Population: Analysis was performed on FAS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | A/H1N1 | 12.0 ratio |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | B2 | 4.76 ratio |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2 | 5.81 ratio |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | B1 | 9.23 ratio |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2 | 2.53 ratio |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | B2 | 2.26 ratio |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | A/H1N1 | 4.50 ratio |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | B1 | 3.30 ratio |
Primary
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Time frame: Within 30 minutes post-vaccination
Population: Analysis was performed on the safety analysis set (SafAS) that included participants who had received one of the study vaccines and had any safety data available; and were analyzed according to the vaccine they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
Time frame: From Day 0 up to 28 days post-vaccination
Population: Analysis was performed on the SafAS.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | SAE | 0 Participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | AESIs | 0 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | SAE | 0 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | AESIs | 0 Participants |
Primary
Number of Participants With Solicited Injection Site and Systemic Reactions
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Time frame: Within 7 days post-vaccination
Population: Analysis was performed on the SafAS. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site Pain | 37 Participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site Erythema | 8 Participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site Swelling | 8 Participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site Induration | 8 Participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site Bruising | 0 Participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Fever | 1 Participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Headache | 9 Participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Malaise | 9 Participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Myalgia | 22 Participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Shivering | 3 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Shivering | 3 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site Pain | 30 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Myalgia | 10 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site Erythema | 7 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Headache | 4 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site Swelling | 2 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Fever | 0 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site Induration | 2 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Malaise | 7 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site Bruising | 0 Participants |
Primary
Number of Participants With Unsolicited Adverse Events
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Time frame: Within 28 days post-vaccination
Population: Analysis was performed on the SafAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Unsolicited Adverse Events | 8 Participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Number of Participants With Unsolicited Adverse Events | 12 Participants |
Primary
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (\>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer \>=10 (1/dilution) at Day 0 and a \>= four-fold increase in post-vaccination titer at Day 28.
Time frame: Day 28 (post-vaccination)
Population: Analysis was performed on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | A/H3N2 | 61.3 percentage of participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | B2 | 50.0 percentage of participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | B1 | 78.8 percentage of participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | A/H1N1 | 86.3 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | A/H1N1 | 50.6 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | A/H3N2 | 28.9 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | B1 | 37.3 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | B2 | 24.1 percentage of participants |
Primary
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Time frame: Day 0 (pre-vaccination)
Population: Analysis was performed on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | A/H1N1 | 33.8 percentage of participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | A/H3N2 | 76.3 percentage of participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | B1 | 81.3 percentage of participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | B2 | 85.0 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | B2 | 86.7 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | A/H1N1 | 36.1 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | B1 | 85.5 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | A/H3N2 | 84.3 percentage of participants |
Primary
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28
Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Time frame: Day 28 (post-vaccination)
Population: Analysis was performed on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | A/H1N1 | 97.5 percentage of participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | B1 | 98.8 percentage of participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | A/H3N2 | 100 percentage of participants |
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | B2 | 100 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | A/H3N2 | 96.4 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | A/H1N1 | 79.5 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | B2 | 100 percentage of participants |
| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | B1 | 98.8 percentage of participants |