Influenza, Human
Conditions
Keywords
Influenza, Vaccine, MF59 adjuvant
Brief summary
This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age.
Interventions
BIOLOGICALaQIV
Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
BIOLOGICALComparator QIV
Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
In order to participate in this study, all subjects must meet ALL of the following inclusion criteria: * Individuals 50 to 64 years of age (i.e. 50 to ≤64 years) on the day of informed consent * Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry * Individuals who can comply with study procedures including follow-up * Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination
Exclusion criteria
In order to participate in this study, all subjects must not meet ANY of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 22 | The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV. |
| Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 22 | The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. The SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR. |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 22 | The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | The GMFI is defined as the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer. |
| Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | Percentage of subjects with a titer ≥1:40 on Day 1, Day 22, and Day 181 as determined by HI assay against each of the four vaccine strains |
| Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Day 1 through Day 7 | Number and percentage of subjects with solicited local and systemic AEs occurring for 7 days following vaccination |
| Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Day 1 through Day 22 | The percentage of subjects with at least one unsolicited AE occurring 21 days following vaccination The severity of AEs is based on the maximum severity associated with a Preferred Term for a reported AE. Related AEs include possibly related AEs, probably related AEs and AEs with missing relatedness assessment. The severity and relatedness of AEs were determined by the investigator. For the any AE summary by severity, a subject with multiple AEs is counted according to the highest severity of their reported AEs. |
| Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | Day 1 through Day 271 | The percentage of subjects with any SAE, AE leading to withdrawal, or AESI during the study period |
| Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22 or Day 181) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. |
| Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 181 | The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV. |
| Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | GMTs on Day 1 (prior to vaccination), Day 22 (3 weeks after vaccination), and Day 181 (6 months after vaccination) as determined by HI assay against each of the four vaccine strains |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | Day 22 | The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV. |
| Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | Day 22 | The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV. |
| Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | Day 22 | The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV. |
Countries
Estonia, Germany, United States
Participant flow
Recruitment details
Subjects were enrolled in the 2021/2022 Northern Hemisphere influenza season from 29 centers in Estonia (6 centers), Germany (11 centers), and the United States (12 centers).
Pre-assignment details
In total, 2044 subjects were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| aQIV Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1 | 1,027 |
| Comparator QIV Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1 | 1,017 |
| Total | 2,044 |
Baseline characteristics
| Characteristic | Total | aQIV | Comparator QIV |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2044 Participants | 1027 Participants | 1017 Participants |
| Age, Continuous | 57.8 years STANDARD_DEVIATION 4.19 | 57.8 years STANDARD_DEVIATION 4.17 | 57.8 years STANDARD_DEVIATION 4.21 |
| Age, Customized 50 to 59 years | 1205 Participants | 609 Participants | 596 Participants |
| Age, Customized 60 to 64 years | 839 Participants | 418 Participants | 421 Participants |
| Comorbidity Risk Score <50 | 1831 Participants | 912 Participants | 919 Participants |
| Comorbidity Risk Score ≥50 | 213 Participants | 115 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 14 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2014 Participants | 1013 Participants | 1001 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 75 Participants | 39 Participants | 36 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 1954 Participants | 982 Participants | 972 Participants |
| Received an influenza vaccination in the previous 3 influenza seasons No | 860 Participants | 441 Participants | 419 Participants |
| Received an influenza vaccination in the previous 3 influenza seasons Yes | 1184 Participants | 586 Participants | 598 Participants |
| Region of Enrollment Estonia | 787 Participants | 391 Participants | 396 Participants |
| Region of Enrollment Germany | 513 Participants | 259 Participants | 254 Participants |
| Region of Enrollment United States | 744 Participants | 377 Participants | 367 Participants |
| Sex: Female, Male Female | 1250 Participants | 635 Participants | 615 Participants |
| Sex: Female, Male Male | 794 Participants | 392 Participants | 402 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1,027 | 0 / 1,016 |
| other Total, other adverse events | 660 / 1,020 | 519 / 1,008 |
| serious Total, serious adverse events | 31 / 1,027 | 31 / 1,016 |
Outcome results
Primary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Time frame: Day 22
Population: Per Protocol Set (PPS) Immunogenicity, defined as all subjects in the Full Analysis Set (FAS) Immunogenicity who: had both Day 1 and Day 22 immunogenicity assessment; correctly received the vaccine (ie, received the vaccine to which the subjects were randomized and at the scheduled time points); had no protocol deviations leading to exclusion as defined prior to unblinding/analysis; were not excluded due to other reasons defined prior to unblinding or analysis. Note: Adjusted GMTs are presented.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 | 731.90 Titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata | 154.40 Titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 | 347.89 Titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria | 144.41 Titer |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 | 313.16 Titer |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 | 586.85 Titer |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria | 143.32 Titer |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata | 145.74 Titer |
Comparison: A/H1N195% CI: [0.738, 0.871]
Comparison: A/H3N295% CI: [0.819, 0.989]
Comparison: B/Yamagata95% CI: [0.88, 1.012]
Comparison: B/Victoria95% CI: [0.923, 1.067]
Primary
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Time frame: Day 22
Population: FAS Immunogenicity, defined as all subjects in the All Enrolled Set who were randomized, received study vaccination and provided immunogenicity data at any time point. Note: Adjusted GMTs are presented.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 | 729.17 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 | 347.09 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata | 155.19 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria | 143.73 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria | 143.74 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 | 589.07 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata | 146.89 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 | 315.69 Titer |
Comparison: A/H1N195% CI: [0.745, 0.876]
Comparison: A/H3N295% CI: [0.829, 0.998]
Comparison: B/Yamagata95% CI: [0.884, 1.014]
Comparison: B/Victoria95% CI: [0.931, 1.075]
Primary
Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. The SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR.
Time frame: Day 1 to Day 22
Population: PPS Immunogenicity
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 | 81.2 percentage of participants |
| aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 | 63.6 percentage of participants |
| aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata | 43.4 percentage of participants |
| aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria | 44.5 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria | 40.6 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 | 76.8 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata | 41.0 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 | 61.8 percentage of participants |
Comparison: B/Victoria95% CI: [-8.31, 0.45]
Comparison: A/H1N195% CI: [-7.97, -0.74]
Comparison: A/H3N295% CI: [-6.14, 2.48]
Comparison: B/Yamagata95% CI: [-6.77, 2]
Secondary
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The GMFI is defined as the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer.
Time frame: Day 1 to Day 181
Population: FAS Immunogenicity
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Fold increase Day 22 HI Titer | 13.07 Fold Increase |
| aQIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Fold increase Day 181 HI Titer | 6.22 Fold Increase |
| aQIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Fold increase Day 22 HI Titer | 7.09 Fold Increase |
| aQIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Fold increase Day 181 HI Titer | 3.29 Fold Increase |
| aQIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Fold increase Day 22 HI Titer | 3.77 Fold Increase |
| aQIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Fold increase Day 181 HI Titer | 2.03 Fold Increase |
| aQIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Fold increase Day 22 HI Titer | 3.73 Fold Increase |
| aQIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Fold increase Day 181 HI Titer | 2.06 Fold Increase |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Fold increase Day 181 HI Titer | 2.05 Fold Increase |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Fold increase Day 22 HI Titer | 11.00 Fold Increase |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Fold increase Day 22 HI Titer | 3.50 Fold Increase |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Fold increase Day 181 HI Titer | 5.47 Fold Increase |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Fold increase Day 22 HI Titer | 3.60 Fold Increase |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Fold increase Day 22 HI Titer | 6.31 Fold Increase |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Fold increase Day 181 HI Titer | 2.01 Fold Increase |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Fold increase Day 181 HI Titer | 3.08 Fold Increase |
Secondary
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Time frame: Day 181
Population: FAS Immunogenicity. Note: Adjusted GMTs are presented.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 | 351.73 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 | 165.17 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata | 83.42 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria | 79.51 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 | 157.34 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 | 306.11 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria | 81.73 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata | 84.53 Titer |
Comparison: A/H1N195% CI: [0.803, 0.944]
Comparison: A/H3N295% CI: [0.88, 1.032]
Comparison: B/Yamagata95% CI: [0.953, 1.077]
Comparison: B/Victoria95% CI: [0.963, 1.098]
Secondary
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
GMTs on Day 1 (prior to vaccination), Day 22 (3 weeks after vaccination), and Day 181 (6 months after vaccination) as determined by HI assay against each of the four vaccine strains
Time frame: Day 1 to Day 181
Population: FAS Immunogenicity. Note: Unadjusted GMTs are presented.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Day 1 GMT | 54.37 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Day 22 GMT | 708.36 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Day 181 GMT | 330.76 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Day 1 GMT | 45.97 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Day 22 GMT | 323.40 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Day 181 GMT | 151.92 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Day 1 GMT | 38.50 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Day 22 GMT | 144.30 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Day 181 GMT | 76.87 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Day 1 GMT | 36.24 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Day 22 GMT | 134.45 Titer |
| aQIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Day 181 GMT | 74.17 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Day 22 GMT | 132.45 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Day 1 GMT | 50.41 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Day 1 GMT | 38.33 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Day 22 GMT | 553.70 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Day 1 GMT | 37.06 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Day 181 GMT | 276.24 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Day 22 GMT | 134.15 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Day 1 GMT | 46.54 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Day 181 GMT | 75.99 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Day 22 GMT | 292.50 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Day 181 GMT | 77.34 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Day 181 GMT | 143.80 Titer |
Secondary
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22 or Day 181) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer.
Time frame: Day 1 to Day 181
Population: FAS Immunogenicity
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Day 22 SCR | 80.8 percentage of participants |
| aQIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Day 181 SCR | 64.5 percentage of participants |
| aQIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Day 22 SCR | 63.4 percentage of participants |
| aQIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Day 181 SCR | 39.4 percentage of participants |
| aQIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Day 22 SCR | 42.9 percentage of participants |
| aQIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Day 181 SCR | 22.4 percentage of participants |
| aQIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Day 22 SCR | 43.9 percentage of participants |
| aQIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Day 181 SCR | 24.3 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Day 181 SCR | 23.6 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Day 22 SCR | 77.1 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Day 22 SCR | 41.1 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 Day 181 SCR | 56.1 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria Day 22 SCR | 40.6 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Day 22 SCR | 61.8 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata Day 181 SCR | 22.4 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 Day 181 SCR | 38.6 percentage of participants |
Secondary
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Percentage of subjects with a titer ≥1:40 on Day 1, Day 22, and Day 181 as determined by HI assay against each of the four vaccine strains
Time frame: Day 1 to Day 181
Population: FAS Immunogenicity
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 HI Titer ≥1:40 at Day 181 | 98.2 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata HI Titer ≥1:40 at Day 22 | 95.9 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 HI Titer ≥1:40 at Day 22 | 97.5 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata HI Titer ≥1:40 at Day 181 | 83.9 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 HI Titer ≥1:40 at Day 22 | 99.7 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria HI Titer ≥1:40 at Day 1 | 58.5 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 HI Titer ≥1:40 at Day 181 | 92.0 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria HI Titer ≥1:40 at Day 22 | 94.4 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 HI Titer ≥1:40 at Day 1 | 60.3 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria HI Titer ≥1:40 at Day 181 | 83.4 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata HI Titer ≥1:40 at Day 1 | 60.8 percentage of participants |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 HI Titer ≥1:40 at Day 1 | 65.2 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata HI Titer ≥1:40 at Day 1 | 61.9 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 HI Titer ≥1:40 at Day 22 | 99.2 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 HI Titer ≥1:40 at Day 181 | 96.3 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 HI Titer ≥1:40 at Day 1 | 61.7 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 HI Titer ≥1:40 at Day 22 | 97.3 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H3N2 HI Titer ≥1:40 at Day 181 | 89.9 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | A/H1N1 HI Titer ≥1:40 at Day 1 | 64.2 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata HI Titer ≥1:40 at Day 22 | 94.6 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Yamagata HI Titer ≥1:40 at Day 181 | 84.0 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria HI Titer ≥1:40 at Day 1 | 60.4 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria HI Titer ≥1:40 at Day 22 | 93.3 percentage of participants |
| Comparator QIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | B/Victoria HI Titer ≥1:40 at Day 181 | 84.3 percentage of participants |
Secondary
Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination
The percentage of subjects with at least one unsolicited AE occurring 21 days following vaccination The severity of AEs is based on the maximum severity associated with a Preferred Term for a reported AE. Related AEs include possibly related AEs, probably related AEs and AEs with missing relatedness assessment. The severity and relatedness of AEs were determined by the investigator. For the any AE summary by severity, a subject with multiple AEs is counted according to the highest severity of their reported AEs.
Time frame: Day 1 through Day 22
Population: Unsolicited Safety Set, defined as all subjects in the All Exposed Set with any unsolicited AE data. Note: Subjects are categorized according to the maximum symptom severity.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aQIV | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Any AE (Mild) | 116 Participants |
| aQIV | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Any AE (Severe) | 2 Participants |
| aQIV | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Any AE (Moderate) | 51 Participants |
| aQIV | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Related AE | 33 Participants |
| aQIV | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Any AE | 169 Participants |
| Comparator QIV | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Related AE | 32 Participants |
| Comparator QIV | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Any AE | 172 Participants |
| Comparator QIV | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Any AE (Mild) | 115 Participants |
| Comparator QIV | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Any AE (Moderate) | 50 Participants |
| Comparator QIV | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Any AE (Severe) | 7 Participants |
Secondary
Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)
The percentage of subjects with any SAE, AE leading to withdrawal, or AESI during the study period
Time frame: Day 1 through Day 271
Population: Unsolicited Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aQIV | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | AESI | 2 Participants |
| aQIV | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | SAE | 31 Participants |
| aQIV | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | Related SAE | 0 Participants |
| aQIV | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | AE leading to study withdrawal | 0 Participants |
| aQIV | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | Death | 1 Participants |
| Comparator QIV | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | Death | 0 Participants |
| Comparator QIV | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | AE leading to study withdrawal | 1 Participants |
| Comparator QIV | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | SAE | 31 Participants |
| Comparator QIV | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | AESI | 0 Participants |
| Comparator QIV | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | Related SAE | 1 Participants |
Secondary
Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination
Number and percentage of subjects with solicited local and systemic AEs occurring for 7 days following vaccination
Time frame: Day 1 through Day 7
Population: Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data including temperature measurements or use of analgesics/antipyretics
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aQIV | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Any Solicited AEs | 672 Participants |
| aQIV | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Any Solicited Local AEs | 508 Participants |
| aQIV | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Any Solicited Systemic AEs | 462 Participants |
| aQIV | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Analgesic/Antipyretic Use | 132 Participants |
| Comparator QIV | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Analgesic/Antipyretic Use | 97 Participants |
| Comparator QIV | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Any Solicited AEs | 541 Participants |
| Comparator QIV | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Any Solicited Systemic AEs | 403 Participants |
| Comparator QIV | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Any Solicited Local AEs | 306 Participants |
Other Pre-specified
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Time frame: Day 22
Population: FAS Immunogenicity. Subgroup analysis by age (50 to 59 years; 60 to 64 years). Note: Adjusted GMTs are presented.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | A/H1N1 (50 to 59 years) | 674.25 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | A/H3N2 (50 to 59 years) | 345.83 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | B/Yamagata (50 to 59 years) | 161.27 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | B/Victoria (50 to 59 years) | 167.60 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | A/H1N1 (60 to 64 years) | 806.65 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | A/H3N2 (60 to 64 years) | 348.59 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | B/Yamagata (60 to 64 years) | 148.20 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | B/Victoria (60 to 64 years) | 119.64 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | B/Victoria (60 to 64 years) | 121.16 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | A/H1N1 (50 to 59 years) | 565.33 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | A/H1N1 (60 to 64 years) | 618.90 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | A/H3N2 (50 to 59 years) | 319.55 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | B/Yamagata (60 to 64 years) | 144.34 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | B/Yamagata (50 to 59 years) | 149.36 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | A/H3N2 (60 to 64 years) | 310.23 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | B/Victoria (50 to 59 years) | 165.81 Titer |
Comparison: A/H1N1 (50 to 59 years)95% CI: [0.751, 0.936]
Comparison: A/H3N2 (50 to 59 years)95% CI: [0.821, 1.04]
Comparison: B/Yamagata (50 to 59 years)95% CI: [0.845, 1.015]
Comparison: B/Victoria (50 to 59 years)95% CI: [0.901, 1.087]
Comparison: A/H1N1 (60 to 64 years)95% CI: [0.681, 0.864]
Comparison: A/H3N2 (60 to 64 years)95% CI: [0.766, 1.033]
Comparison: B/Yamagata (60 to 64 years)95% CI: [0.879, 1.079]
Comparison: B/Victoria (60 to 64 years)95% CI: [0.905, 1.133]
Other Pre-specified
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Time frame: Day 22
Population: FAS Immunogenicity. Subgroup analysis by comorbidity risk score (\<50; ≥50). Note: Adjusted GMTs are presented.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | A/H1N1 (Comorbidity Risk Score <50) | 715.26 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | A/H3N2 (Comorbidity Risk Score <50) | 337.43 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | B/Yamagata (Comorbidity Risk Score <50) | 150.17 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | B/Victoria (Comorbidity Risk Score <50) | 139.76 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | A/H1N1 (Comorbidity Risk Score ≥50) | 812.59 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | A/H3N2 (Comorbidity Risk Score ≥50) | 453.60 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | B/Yamagata (Comorbidity Risk Score ≥50) | 198.10 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | B/Victoria (Comorbidity Risk Score ≥50) | 174.79 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | B/Victoria (Comorbidity Risk Score ≥50) | 158.12 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | A/H1N1 (Comorbidity Risk Score <50) | 586.42 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | A/H1N1 (Comorbidity Risk Score ≥50) | 573.86 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | A/H3N2 (Comorbidity Risk Score <50) | 314.75 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | B/Yamagata (Comorbidity Risk Score ≥50) | 153.05 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | B/Yamagata (Comorbidity Risk Score <50) | 145.98 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | A/H3N2 (Comorbidity Risk Score ≥50) | 333.16 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | B/Victoria (Comorbidity Risk Score <50) | 141.58 Titer |
Comparison: A/H1N1 (Comorbidity Risk Score \<50)95% CI: [0.752, 0.894]
Comparison: A/H3N2 (Comorbidity Risk Score \<50)95% CI: [0.846, 1.029]
Comparison: B/Yamagata (Comorbidity Risk Score \<50)95% CI: [0.904, 1.046]
Comparison: B/Victoria (Comorbidity Risk Score \<50)95% CI: [0.938, 1.094]
Comparison: A/H1N1 (Comorbidity Risk Score ≥50)95% CI: [0.553, 0.902]
Comparison: A/H3N2 (Comorbidity Risk Score ≥50)95% CI: [0.549, 0.982]
Comparison: B/Yamagata (Comorbidity Risk Score ≥50)95% CI: [0.638, 0.935]
Comparison: B/Victoria (Comorbidity Risk Score ≥50)95% CI: [0.739, 1.107]
Other Pre-specified
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Time frame: Day 22
Population: FAS Immunogenicity. Subgroup analysis by influenza vaccination history (Received at least one influenza vaccination within the previous 3 influenza seasons: yes; no). Note: Adjusted GMTs are presented.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | A/H1N1 (yes) | 648.75 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | A/H3N2 (yes) | 279.61 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | B/Yamagata (yes) | 116.48 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | B/Victoria (yes) | 101.89 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | A/H1N1 (no) | 755.46 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | A/H3N2 (no) | 389.77 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | B/Yamagata (no) | 188.78 Titer |
| aQIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | B/Victoria (no) | 185.31 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | B/Victoria (no) | 186.65 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | A/H1N1 (yes) | 547.54 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | A/H1N1 (no) | 582.90 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | A/H3N2 (yes) | 282.44 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | B/Yamagata (no) | 178.45 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | B/Yamagata (yes) | 110.37 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | A/H3N2 (no) | 312.38 Titer |
| Comparator QIV | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | B/Victoria (yes) | 101.59 Titer |
Comparison: A/H1N1 (yes)95% CI: [0.761, 0.935]
Comparison: A/H3N2 (yes)95% CI: [0.904, 1.128]
Comparison: B/Yamagata (yes)95% CI: [0.883, 1.016]
Comparison: B/Victoria (yes)95% CI: [0.926, 1.073]
Comparison: A/H1N1 (no)95% CI: [0.677, 0.88]
Comparison: A/H3N2 (no)95% CI: [0.683, 0.941]
Comparison: B/Yamagata (no)95% CI: [0.831, 1.076]
Comparison: B/Victoria (no)95% CI: [0.881, 1.151]