Influenza, Human
Conditions
Keywords
Influenza Vaccine
Brief summary
This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.
Interventions
BIOLOGICALQIVc
QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
BIOLOGICALComparator
Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The trial is designed as an observer-blind study. During the treatment period of the study, only designated, trained unblinded personnel will be responsible for administering the study vaccines to the subjects.
Eligibility
Sex/Gender
ALL
Age
6 Months to 47 Months
Healthy volunteers
Yes
Inclusion criteria
In order to participate in this study, all subjects must meet all of the inclusion criteria described. * Individuals of 6 through 47 months of age on the day of informed consent. * Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed 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. * Individuals in generally good health as per the Investigator's medical judgement. If applicable, prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.
Exclusion criteria
* Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours. * History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study. * Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination. * A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis. * Abnormal function of the immune system resulting from a clinical condition * Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent. * Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism. Additional eligibility criteria are provided in the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) | First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms |
| Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) | First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) | First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season |
| Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects | The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains HI = hemagglutination inhibition Adjusted GMTs are presented |
| Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects | The measures for immunogenicity are determined by a HI assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination HI titer ≥1:40, or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects | The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer Adjusted GMRs are presented |
| Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects | The measures for immunogenicity are determined by a microneutralization (MN) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains |
| Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) | First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects | The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination MN titer over the pre-vaccination MN titer |
| Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects | Percentage of subjects with solicited local and systemic AEs assessed for 7 days following each vaccination in the QIVc group and in the comparator group |
| Safety Endpoint: Percentage of Subjects With Unsolicited AEs | 28 days after each vaccination in the treatment period, ie, Day 1 to Day 29 for previously vaccinated subjects and Day 1 to Day 57 for not previously vaccinated subjects | Percentage of subjects with any unsolicited AEs assessed in the QIVc group and in the comparator group until 28 days after each vaccination |
| Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | Day 1 through Study Completion, ie, Day 1 to Day 181 or end of influenza season, whichever was longer, for previously vaccinated subjects and Day 1 to Day 209 or end of influenza season, whichever was longer, for not previously vaccinated subjects | Percentage of subjects with serious adverse events (SAEs), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events in the QIVc group and in the comparator group Note: The time frame for assessment of these AEs was Day 1 through Study Completion as indicated below. Subjects aged 6 months through 11 months at enrollment in countries without NeisVac-C vaccine marketing authorization had an additional study visit 28 days later (ie, Day 237). |
| Safety Endpoint: Percentage of Subjects With Medically-attended AEs | If a subject experienced an ILI during approximately 8 months of study participation, medically-attended AEs were collected for the 30-day period after onset of the ILI (defined as the first day that a subject meets the criteria for protocol-defined ILI) | Percentage of subjects with medically-attended AEs within 30 days after ILI onset in the QIVc group and in the comparator group |
| Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects | The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer |
| Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) | First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms |
Countries
Bangladesh, Bulgaria, Czechia, Estonia, Honduras, Latvia, Malaysia, New Zealand, Pakistan, Philippines, Poland, Romania, South Africa, Thailand, Ukraine
Participant flow
Pre-assignment details
Treatment period: Previously vaccinated subjects: Day of vaccination to 28 days after vaccination (Day 1-Day 29); Not previously vaccinated subjects: Day of first vaccination to 28 days after second vaccination (Day 1-Day 57) Study completion: At end of influenza season and at least 180 days after last vaccination during treatment period, whichever was longer (previously vaccinated subjects: Day 181/end of influenza season; not previously vaccinated subjects: Day 209/end of influenza season)
Participants by arm
| Arm | Count |
|---|---|
| QIVc Cell-derived Quadrivalent Influenza Vaccine
QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study. | 2,860 |
| Comparator Non-influenza Comparator
Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C) | 2,863 |
| Total | 5,723 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 19 | 25 |
| Overall Study | Other | 9 | 23 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 37 | 45 |
Baseline characteristics
| Characteristic | Comparator | QIVc | Total |
|---|---|---|---|
| Age, Continuous | 25.9 months STANDARD_DEVIATION 11.9 | 25.8 months STANDARD_DEVIATION 11.9 | 25.9 months STANDARD_DEVIATION 11.9 |
| Age, Customized 24 months through 47 months | 1599 Participants | 1592 Participants | 3191 Participants |
| Age, Customized 6 months through 23 months | 1264 Participants | 1268 Participants | 2532 Participants |
| Body mass index | 16.61 kg/m2 STANDARD_DEVIATION 2.9 | 16.51 kg/m2 STANDARD_DEVIATION 2.2 | 16.56 kg/m2 STANDARD_DEVIATION 2.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 157 Participants | 155 Participants | 312 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2697 Participants | 2696 Participants | 5393 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 9 Participants | 18 Participants |
| Participants enrolled in each influenza season Season 1 | 349 Participants | 344 Participants | 693 Participants |
| Participants enrolled in each influenza season Season 2 | 489 Participants | 497 Participants | 986 Participants |
| Participants enrolled in each influenza season Season 3 | 521 Participants | 525 Participants | 1046 Participants |
| Participants enrolled in each influenza season Season 4 | 504 Participants | 496 Participants | 1000 Participants |
| Participants enrolled in each influenza season Season 5 | 1000 Participants | 998 Participants | 1998 Participants |
| Previous influenza vaccination Not previously vaccinated | 2801 Participants | 2812 Participants | 5613 Participants |
| Previous influenza vaccination Previously vaccinated | 62 Participants | 48 Participants | 110 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1096 Participants | 1098 Participants | 2194 Participants |
| Race/Ethnicity, Customized Black or African American | 349 Participants | 348 Participants | 697 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 183 Participants | 175 Participants | 358 Participants |
| Race/Ethnicity, Customized White | 1234 Participants | 1239 Participants | 2473 Participants |
| Region of Enrollment Bangladesh | 99 Participants | 101 Participants | 200 Participants |
| Region of Enrollment Bulgaria | 135 Participants | 131 Participants | 266 Participants |
| Region of Enrollment Czechia | 38 Participants | 41 Participants | 79 Participants |
| Region of Enrollment Estonia | 621 Participants | 625 Participants | 1246 Participants |
| Region of Enrollment Honduras | 151 Participants | 147 Participants | 298 Participants |
| Region of Enrollment Latvia | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment Malaysia | 34 Participants | 31 Participants | 65 Participants |
| Region of Enrollment New Zealand | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment Pakistan | 282 Participants | 279 Participants | 561 Participants |
| Region of Enrollment Philippines | 609 Participants | 608 Participants | 1217 Participants |
| Region of Enrollment Poland | 220 Participants | 217 Participants | 437 Participants |
| Region of Enrollment Romania | 33 Participants | 38 Participants | 71 Participants |
| Region of Enrollment South Africa | 380 Participants | 376 Participants | 756 Participants |
| Region of Enrollment Thailand | 69 Participants | 72 Participants | 141 Participants |
| Region of Enrollment Ukraine | 183 Participants | 184 Participants | 367 Participants |
| Sex: Female, Male Female | 1333 Participants | 1418 Participants | 2751 Participants |
| Sex: Female, Male Male | 1530 Participants | 1442 Participants | 2972 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 2,856 | 2 / 2,841 |
| other Total, other adverse events | 2,050 / 2,856 | 2,126 / 2,841 |
| serious Total, serious adverse events | 64 / 2,856 | 84 / 2,841 |
Outcome results
Primary
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine
First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Time frame: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Population: FAS Efficacy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QIVc | Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine | 44 Cases |
| Comparator | Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine | 82 Cases |
97.5% CI: [19.19, 65.11]
Primary
Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match
First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms
Time frame: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Population: Full Analysis Set (FAS) Efficacy, defined as all subjects in the All Enrolled Set who were randomized, received at least one dose of study vaccination, and were evaluated for efficacy at more than 14 days after the last vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QIVc | Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match | 104 Cases |
| Comparator | Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match | 173 Cases |
97.98% CI: [21.55, 56.02]
Secondary
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine
First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Time frame: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Population: FAS Efficacy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QIVc | Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine | 20 Cases |
| Comparator | Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine | 43 Cases |
95% CI: [22.55, 73.26]
Secondary
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine
First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Time frame: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Population: FAS Efficacy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QIVc | Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine | 61 Cases |
| Comparator | Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine | 121 Cases |
95% CI: [32.83, 63.77]
Secondary
Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine
First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season
Time frame: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Population: FAS Efficacy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QIVc | Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine | 0 Cases |
| Comparator | Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine | 9 Cases |
Secondary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)
The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer Adjusted GMRs are presented
Time frame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Population: FAS Immunogenicity
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIVc | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H1N1 GMR HI Titer | 3.36 Geometric mean ratio |
| QIVc | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H3N2 GMR HI Titer | NA Geometric mean ratio |
| QIVc | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Yamagata GMR HI Titer | 2.52 Geometric mean ratio |
| QIVc | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Victoria GMR HI Titer | 2.01 Geometric mean ratio |
| Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H3N2 GMR HI Titer | NA Geometric mean ratio |
| Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H1N1 GMR HI Titer | 1.53 Geometric mean ratio |
| Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Victoria GMR HI Titer | 0.90 Geometric mean ratio |
| Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Yamagata GMR HI Titer | 0.92 Geometric mean ratio |
| QIVc (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H3N2 GMR HI Titer | 7.43 Geometric mean ratio |
| QIVc (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H1N1 GMR HI Titer | 3.71 Geometric mean ratio |
| QIVc (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Yamagata GMR HI Titer | 3.38 Geometric mean ratio |
| QIVc (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Victoria GMR HI Titer | 1.79 Geometric mean ratio |
| Comparator (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H1N1 GMR HI Titer | 0.67 Geometric mean ratio |
| Comparator (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H3N2 GMR HI Titer | 0.62 Geometric mean ratio |
| Comparator (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Yamagata GMR HI Titer | 1.96 Geometric mean ratio |
| Comparator (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Victoria GMR HI Titer | 0.94 Geometric mean ratio |
| QIVc (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Yamagata GMR HI Titer | 1.95 Geometric mean ratio |
| QIVc (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H3N2 GMR HI Titer | NA Geometric mean ratio |
| QIVc (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Victoria GMR HI Titer | 1.43 Geometric mean ratio |
| QIVc (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H1N1 GMR HI Titer | 6.28 Geometric mean ratio |
| Comparator (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Yamagata GMR HI Titer | 0.75 Geometric mean ratio |
| Comparator (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H3N2 GMR HI Titer | NA Geometric mean ratio |
| Comparator (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H1N1 GMR HI Titer | 0.70 Geometric mean ratio |
| Comparator (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Victoria GMR HI Titer | 0.71 Geometric mean ratio |
| QIVc (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H3N2 GMR HI Titer | 1.81 Geometric mean ratio |
| QIVc (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Yamagata GMR HI Titer | 2.03 Geometric mean ratio |
| QIVc (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Victoria GMR HI Titer | 4.44 Geometric mean ratio |
| QIVc (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H1N1 GMR HI Titer | 2.59 Geometric mean ratio |
| Comparator (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H1N1 GMR HI Titer | 1.42 Geometric mean ratio |
| Comparator (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Victoria GMR HI Titer | 0.85 Geometric mean ratio |
| Comparator (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H3N2 GMR HI Titer | 1.19 Geometric mean ratio |
| Comparator (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Yamagata GMR HI Titer | 0.68 Geometric mean ratio |
| QIVc (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Victoria GMR HI Titer | 32.55 Geometric mean ratio |
| QIVc (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H1N1 GMR HI Titer | 19.20 Geometric mean ratio |
| QIVc (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Yamagata GMR HI Titer | 8.04 Geometric mean ratio |
| QIVc (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H3N2 GMR HI Titer | 7.14 Geometric mean ratio |
| Comparator (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Yamagata GMR HI Titer | 1.20 Geometric mean ratio |
| Comparator (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H1N1 GMR HI Titer | 3.20 Geometric mean ratio |
| Comparator (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | B/Victoria GMR HI Titer | 2.95 Geometric mean ratio |
| Comparator (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | A/H3N2 GMR HI Titer | 0.80 Geometric mean ratio |
Secondary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)
The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination MN titer over the pre-vaccination MN titer
Time frame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Population: FAS Immunogenicity
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIVc | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H1N1 GMR MN Titer | 16.16 Geometric mean ratio |
| QIVc | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H3N2 GMR MN Titer | 3.28 Geometric mean ratio |
| QIVc | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Yamagata GMR MN Titer | 3.93 Geometric mean ratio |
| QIVc | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Victoria GMR MN Titer | 2.17 Geometric mean ratio |
| Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H3N2 GMR MN Titer | 1.32 Geometric mean ratio |
| Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H1N1 GMR MN Titer | 1.70 Geometric mean ratio |
| Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Victoria GMR MN Titer | 1.07 Geometric mean ratio |
| Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Yamagata GMR MN Titer | 1.30 Geometric mean ratio |
| QIVc (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H3N2 GMR MN Titer | 2.14 Geometric mean ratio |
| QIVc (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H1N1 GMR MN Titer | 8.12 Geometric mean ratio |
| QIVc (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Yamagata GMR MN Titer | 3.05 Geometric mean ratio |
| QIVc (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Victoria GMR MN Titer | 1.04 Geometric mean ratio |
| Comparator (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H1N1 GMR MN Titer | 1.15 Geometric mean ratio |
| Comparator (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H3N2 GMR MN Titer | 0.93 Geometric mean ratio |
| Comparator (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Yamagata GMR MN Titer | 1.38 Geometric mean ratio |
| Comparator (Season 2) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Victoria GMR MN Titer | 1.01 Geometric mean ratio |
| QIVc (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Yamagata GMR MN Titer | 3.15 Geometric mean ratio |
| QIVc (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H3N2 GMR MN Titer | 5.92 Geometric mean ratio |
| QIVc (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Victoria GMR MN Titer | 2.74 Geometric mean ratio |
| QIVc (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H1N1 GMR MN Titer | 17.55 Geometric mean ratio |
| Comparator (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Yamagata GMR MN Titer | 1.10 Geometric mean ratio |
| Comparator (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H3N2 GMR MN Titer | 1.01 Geometric mean ratio |
| Comparator (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H1N1 GMR MN Titer | 0.81 Geometric mean ratio |
| Comparator (Season 3) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Victoria GMR MN Titer | 0.92 Geometric mean ratio |
| QIVc (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H3N2 GMR MN Titer | 2.74 Geometric mean ratio |
| QIVc (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Yamagata GMR MN Titer | 1.82 Geometric mean ratio |
| QIVc (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Victoria GMR MN Titer | 16.90 Geometric mean ratio |
| QIVc (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H1N1 GMR MN Titer | 2.37 Geometric mean ratio |
| Comparator (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H1N1 GMR MN Titer | 1.23 Geometric mean ratio |
| Comparator (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Victoria GMR MN Titer | 0.86 Geometric mean ratio |
| Comparator (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H3N2 GMR MN Titer | 1.16 Geometric mean ratio |
| Comparator (Season 4) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Yamagata GMR MN Titer | 1.11 Geometric mean ratio |
| QIVc (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Victoria GMR MN Titer | 31.51 Geometric mean ratio |
| QIVc (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H1N1 GMR MN Titer | 3.47 Geometric mean ratio |
| QIVc (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Yamagata GMR MN Titer | 3.81 Geometric mean ratio |
| QIVc (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H3N2 GMR MN Titer | 4.40 Geometric mean ratio |
| Comparator (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Yamagata GMR MN Titer | 1.19 Geometric mean ratio |
| Comparator (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H1N1 GMR MN Titer | 0.85 Geometric mean ratio |
| Comparator (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | B/Victoria GMR MN Titer | 1.42 Geometric mean ratio |
| Comparator (Season 5) | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | A/H3N2 GMR MN Titer | 0.95 Geometric mean ratio |
Secondary
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains HI = hemagglutination inhibition Adjusted GMTs are presented
Time frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Population: FAS Immunogenicity, defined as all subjects in the All Enrolled Set who were randomized, received at least one study vaccination, and provided evaluable serum samples at both baseline (Day 1) and 28 days after last vaccination (Day 29/57)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 1 HI GMT | NA Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 1 HI GMT | 11.66 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 29/57 HI GMT | 126.39 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 29/57 HI GMT | 18.94 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 29/57 HI GMT | NA Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 1 HI GMT | 7.40 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 29/57 HI GMT | 14.97 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 1 HI GMT | 40.06 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 29/57 HI GMT | NA Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 1 HI GMT | 44.28 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 1 HI GMT | 11.53 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 29/57 HI GMT | 7.01 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 1 HI GMT | NA Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 1 HI GMT | 8.36 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 29/57 HI GMT | 6.90 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 29/57 HI GMT | 60.33 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 1 HI GMT | 12.21 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 29/57 HI GMT | 23.65 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 1 HI GMT | 22.99 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 29/57 HI GMT | 95.36 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 1 HI GMT | 9.87 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 29/57 HI GMT | 16.84 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 29/57 HI GMT | 60.77 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 1 HI GMT | 9.37 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 29/57 HI GMT | 11.24 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 1 HI GMT | 9.31 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 1 HI GMT | 14.14 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 1 HI GMT | 27.50 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 29/57 HI GMT | 8.79 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 29/57 HI GMT | 8.82 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 1 HI GMT | 8.22 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 29/57 HI GMT | 13.57 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 29/57 HI GMT | 9.54 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 29/57 HI GMT | NA Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 1 HI GMT | 8.34 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 1 HI GMT | 10.15 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 29/57 HI GMT | 49.38 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 1 HI GMT | NA Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 29/57 HI GMT | 13.85 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 1 HI GMT | 7.65 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 1 HI GMT | 9.39 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 1 HI GMT | NA Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 29/57 HI GMT | NA Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 1 HI GMT | 7.54 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 29/57 HI GMT | 5.26 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 29/57 HI GMT | 5.45 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 29/57 HI GMT | 4.88 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 1 HI GMT | 8.72 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 1 HI GMT | 46.38 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 1 HI GMT | 8.96 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 29/57 HI GMT | 23.92 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 1 HI GMT | 5.82 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 29/57 HI GMT | 13.80 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 1 HI GMT | 57.83 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 29/57 HI GMT | 149.01 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 29/57 HI GMT | 67.88 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 29/57 HI GMT | 4.70 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 1 HI GMT | 6.08 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 1 HI GMT | 9.49 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 29/57 HI GMT | 81.71 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 29/57 HI GMT | 4.67 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 29/57 HI GMT | 38.85 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 1 HI GMT | 35.62 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 1 HI GMT | 58.00 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 29/57 HI GMT | 539.53 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 1 HI GMT | 7.30 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 1 HI GMT | 82.67 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 29/57 HI GMT | 53.72 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 1 HI GMT | 13.60 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 1 HI GMT | 7.84 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 29/57 HI GMT | 440.30 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 29/57 HI GMT | 362.71 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 29/57 HI GMT | 57.87 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 29/57 HI GMT | 8.04 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Yamagata Day 1 HI GMT | 7.35 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H3N2 Day 1 HI GMT | 120.80 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 1 HI GMT | 13.94 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | A/H1N1 Day 29/57 HI GMT | 60.84 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 1 HI GMT | 5.92 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | B/Victoria Day 29/57 HI GMT | 45.34 Geometric mean titer |
Secondary
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
The measures for immunogenicity are determined by a microneutralization (MN) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
Time frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Population: FAS Immunogenicity
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 29/57 MN GMT | 278.89 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 29/57 MN GMT | 14.23 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 1 MN GMT | 22.06 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 29/57 MN GMT | 329.08 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 1 MN GMT | 6.92 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 29/57 MN GMT | 27.55 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 1 MN GMT | 6.07 Geometric mean titer |
| QIVc | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 1 MN GMT | 76.91 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 29/57 MN GMT | 36.24 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 29/57 MN GMT | 7.00 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 29/57 MN GMT | 88.67 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 1 MN GMT | 66.14 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 1 MN GMT | 6.64 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 29/57 MN GMT | 10.95 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 1 MN GMT | 31.10 Geometric mean titer |
| Comparator | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 1 MN GMT | 6.29 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 29/57 MN GMT | 5.29 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 1 MN GMT | 4.96 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 1 MN GMT | 57.54 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 29/57 MN GMT | 283.42 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 1 MN GMT | 4.99 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 29/57 MN GMT | 473.15 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 1 MN GMT | 65.25 Geometric mean titer |
| QIVc (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 29/57 MN GMT | 12.04 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 1 MN GMT | 55.89 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 1 MN GMT | 60.03 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 1 MN GMT | 5.18 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 29/57 MN GMT | 66.69 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 29/57 MN GMT | 5.26 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 1 MN GMT | 4.80 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 29/57 MN GMT | 126.59 Geometric mean titer |
| Comparator (Season 2) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 29/57 MN GMT | 5.31 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 29/57 MN GMT | 55.17 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 29/57 MN GMT | 459.87 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 1 MN GMT | 15.33 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 29/57 MN GMT | 57.93 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 29/57 MN GMT | 26.81 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 1 MN GMT | 9.09 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 1 MN GMT | 61.40 Geometric mean titer |
| QIVc (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 1 MN GMT | 7.02 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 29/57 MN GMT | 10.49 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 29/57 MN GMT | 9.65 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 1 MN GMT | 10.71 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 29/57 MN GMT | 19.32 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 1 MN GMT | 8.33 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 1 MN GMT | 15.26 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 29/57 MN GMT | 19.24 Geometric mean titer |
| Comparator (Season 3) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 1 MN GMT | 43.43 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 1 MN GMT | 53.41 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 29/57 MN GMT | 35.99 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 1 MN GMT | 17.70 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 29/57 MN GMT | 84.60 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 29/57 MN GMT | 121.02 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 29/57 MN GMT | 86.91 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 1 MN GMT | 8.79 Geometric mean titer |
| QIVc (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 1 MN GMT | 32.15 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 29/57 MN GMT | 5.99 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 1 MN GMT | 7.72 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 29/57 MN GMT | 52.11 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 29/57 MN GMT | 46.51 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 1 MN GMT | 35.32 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 29/57 MN GMT | 14.78 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 1 MN GMT | 15.77 Geometric mean titer |
| Comparator (Season 4) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 1 MN GMT | 54.11 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 1 MN GMT | 26.08 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 1 MN GMT | 51.81 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 29/57 MN GMT | 352.09 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 29/57 MN GMT | 169.24 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 1 MN GMT | 15.97 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 29/57 MN GMT | 938.65 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 29/57 MN GMT | 139.97 Geometric mean titer |
| QIVc (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 1 MN GMT | 113.94 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 29/57 MN GMT | 39.32 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 1 MN GMT | 115.49 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H1N1 Day 29/57 MN GMT | 86.61 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 1 MN GMT | 25.98 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | A/H3N2 Day 29/57 MN GMT | 30.22 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 1 MN GMT | 45.20 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Yamagata Day 29/57 MN GMT | 49.34 Geometric mean titer |
| Comparator (Season 5) | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | B/Victoria Day 1 MN GMT | 12.20 Geometric mean titer |
Secondary
Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)
The measures for immunogenicity are determined by a HI assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination HI titer ≥1:40, or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer
Time frame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Population: FAS Immunogenicity
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H1N1 SCR HI Titer | 45.54 Percentage of participants |
| QIVc | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Victoria SCR HI Titer | 24.11 Percentage of participants |
| QIVc | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Yamagata SCR HI Titer | 37.50 Percentage of participants |
| QIVc | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H3N2 SCR HI Titer | NA Percentage of participants |
| Comparator | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H3N2 SCR HI Titer | NA Percentage of participants |
| Comparator | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Yamagata SCR HI Titer | 3.70 Percentage of participants |
| Comparator | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H1N1 SCR HI Titer | 12.04 Percentage of participants |
| Comparator | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Victoria SCR HI Titer | 2.78 Percentage of participants |
| QIVc (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Yamagata SCR HI Titer | 24.30 Percentage of participants |
| QIVc (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H1N1 SCR HI Titer | 57.01 Percentage of participants |
| QIVc (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Victoria SCR HI Titer | 13.08 Percentage of participants |
| QIVc (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H3N2 SCR HI Titer | 70.09 Percentage of participants |
| Comparator (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Yamagata SCR HI Titer | 6.31 Percentage of participants |
| Comparator (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Victoria SCR HI Titer | 0.90 Percentage of participants |
| Comparator (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H3N2 SCR HI Titer | 6.31 Percentage of participants |
| Comparator (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H1N1 SCR HI Titer | 3.60 Percentage of participants |
| QIVc (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H1N1 SCR HI Titer | 68.47 Percentage of participants |
| QIVc (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H3N2 SCR HI Titer | NA Percentage of participants |
| QIVc (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Yamagata SCR HI Titer | 23.42 Percentage of participants |
| QIVc (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Victoria SCR HI Titer | 9.91 Percentage of participants |
| Comparator (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H1N1 SCR HI Titer | 2.68 Percentage of participants |
| Comparator (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H3N2 SCR HI Titer | NA Percentage of participants |
| Comparator (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Victoria SCR HI Titer | 0.00 Percentage of participants |
| Comparator (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Yamagata SCR HI Titer | 0.90 Percentage of participants |
| QIVc (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Victoria SCR HI Titer | 42.53 Percentage of participants |
| QIVc (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H1N1 SCR HI Titer | 29.89 Percentage of participants |
| QIVc (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H3N2 SCR HI Titer | 44.83 Percentage of participants |
| QIVc (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Yamagata SCR HI Titer | 29.89 Percentage of participants |
| Comparator (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Yamagata SCR HI Titer | 1.18 Percentage of participants |
| Comparator (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H1N1 SCR HI Titer | 4.71 Percentage of participants |
| Comparator (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H3N2 SCR HI Titer | 28.24 Percentage of participants |
| Comparator (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Victoria SCR HI Titer | 3.53 Percentage of participants |
| QIVc (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H1N1 SCR HI Titer | 75.00 Percentage of participants |
| QIVc (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H3N2 SCR HI Titer | 84.26 Percentage of participants |
| QIVc (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Yamagata SCR HI Titer | 66.67 Percentage of participants |
| QIVc (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Victoria SCR HI Titer | 80.56 Percentage of participants |
| Comparator (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Victoria SCR HI Titer | 8.33 Percentage of participants |
| Comparator (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H1N1 SCR HI Titer | 12.96 Percentage of participants |
| Comparator (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | A/H3N2 SCR HI Titer | 15.74 Percentage of participants |
| Comparator (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | B/Yamagata SCR HI Titer | 3.70 Percentage of participants |
Secondary
Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)
The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer
Time frame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Population: FAS Immunogenicity
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H1N1 SCR (%) MN Titer | 73.21 Percentage of participants |
| QIVc | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H3N2 SCR (%) MN Titer | 38.39 Percentage of participants |
| QIVc | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Yamagata SCR (%) MN Titer | 46.43 Percentage of participants |
| QIVc | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Victoria SCR (%) MN Titer | 20.54 Percentage of participants |
| Comparator | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H3N2 SCR (%) MN Titer | 4.63 Percentage of participants |
| Comparator | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H1N1 SCR (%) MN Titer | 2.78 Percentage of participants |
| Comparator | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Victoria SCR (%) MN Titer | 0.93 Percentage of participants |
| Comparator | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Yamagata SCR (%) MN Titer | 0.93 Percentage of participants |
| QIVc (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H3N2 SCR (%) MN Titer | 20.56 Percentage of participants |
| QIVc (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H1N1 SCR (%) MN Titer | 74.77 Percentage of participants |
| QIVc (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Yamagata SCR (%) MN Titer | 30.84 Percentage of participants |
| QIVc (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Victoria SCR (%) MN Titer | 0.93 Percentage of participants |
| Comparator (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H1N1 SCR (%) MN Titer | 4.50 Percentage of participants |
| Comparator (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H3N2 SCR (%) MN Titer | 1.80 Percentage of participants |
| Comparator (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Yamagata SCR (%) MN Titer | 3.60 Percentage of participants |
| Comparator (Season 2) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Victoria SCR (%) MN Titer | 2.70 Percentage of participants |
| QIVc (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Yamagata SCR (%) MN Titer | 36.94 Percentage of participants |
| QIVc (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H3N2 SCR (%) MN Titer | 57.66 Percentage of participants |
| QIVc (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Victoria SCR (%) MN Titer | 25.23 Percentage of participants |
| QIVc (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H1N1 SCR (%) MN Titer | 87.39 Percentage of participants |
| Comparator (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Yamagata SCR (%) MN Titer | 4.46 Percentage of participants |
| Comparator (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H3N2 SCR (%) MN Titer | 1.79 Percentage of participants |
| Comparator (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H1N1 SCR (%) MN Titer | 4.46 Percentage of participants |
| Comparator (Season 3) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Victoria SCR (%) MN Titer | 0.89 Percentage of participants |
| QIVc (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H3N2 SCR (%) MN Titer | 33.33 Percentage of participants |
| QIVc (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Yamagata SCR (%) MN Titer | 19.54 Percentage of participants |
| QIVc (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Victoria SCR (%) MN Titer | 87.36 Percentage of participants |
| QIVc (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H1N1 SCR (%) MN Titer | 32.18 Percentage of participants |
| Comparator (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H1N1 SCR (%) MN Titer | 7.06 Percentage of participants |
| Comparator (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Victoria SCR (%) MN Titer | 7.06 Percentage of participants |
| Comparator (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H3N2 SCR (%) MN Titer | 10.59 Percentage of participants |
| Comparator (Season 4) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Yamagata SCR (%) MN Titer | 4.71 Percentage of participants |
| QIVc (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Victoria SCR (%) MN Titer | 94.44 Percentage of participants |
| QIVc (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H1N1 SCR (%) MN Titer | 68.52 Percentage of participants |
| QIVc (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Yamagata SCR (%) MN Titer | 54.63 Percentage of participants |
| QIVc (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H3N2 SCR (%) MN Titer | 71.30 Percentage of participants |
| Comparator (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Yamagata SCR (%) MN Titer | 7.41 Percentage of participants |
| Comparator (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H1N1 SCR (%) MN Titer | 15.74 Percentage of participants |
| Comparator (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | B/Victoria SCR (%) MN Titer | 9.26 Percentage of participants |
| Comparator (Season 5) | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | A/H3N2 SCR (%) MN Titer | 15.74 Percentage of participants |
Secondary
Safety Endpoint: Percentage of Subjects With Medically-attended AEs
Percentage of subjects with medically-attended AEs within 30 days after ILI onset in the QIVc group and in the comparator group
Time frame: If a subject experienced an ILI during approximately 8 months of study participation, medically-attended AEs were collected for the 30-day period after onset of the ILI (defined as the first day that a subject meets the criteria for protocol-defined ILI)
Population: Unsolicited Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QIVc | Safety Endpoint: Percentage of Subjects With Medically-attended AEs | 28.9 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With Medically-attended AEs | 32.6 Percentage of participants |
Secondary
Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
Percentage of subjects with serious adverse events (SAEs), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events in the QIVc group and in the comparator group Note: The time frame for assessment of these AEs was Day 1 through Study Completion as indicated below. Subjects aged 6 months through 11 months at enrollment in countries without NeisVac-C vaccine marketing authorization had an additional study visit 28 days later (ie, Day 237).
Time frame: Day 1 through Study Completion, ie, Day 1 to Day 181 or end of influenza season, whichever was longer, for previously vaccinated subjects and Day 1 to Day 209 or end of influenza season, whichever was longer, for not previously vaccinated subjects
Population: Unsolicited Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | Related SAE | 0 Percentage of participants |
| QIVc | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | AE leading to study withdrawal | 0 Percentage of participants |
| QIVc | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | NOCD | 0.7 Percentage of participants |
| QIVc | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | AE leading to study vaccine withdrawal | 0 Percentage of participants |
| QIVc | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | SAE | 2.2 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | AE leading to study vaccine withdrawal | 0.1 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | SAE | 3.0 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | Related SAE | 0.04 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | NOCD | 0.4 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | AE leading to study withdrawal | 0 Percentage of participants |
Secondary
Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Percentage of subjects with solicited local and systemic AEs assessed for 7 days following each vaccination in the QIVc group and in the comparator group
Time frame: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Population: Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data indicating the occurrence or lack of occurrence of solicited AEs, ie, a subject does not have to have any solicited AEs to be included in this population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc | Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs | 55.8 Percentage of participants |
| QIVc | Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 32.3 Percentage of participants |
| QIVc | Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 40.9 Percentage of participants |
| QIVc | Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/Antipyretic Use | 14.5 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Analgesic/Antipyretic Use | 15.0 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs | 60.8 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 42.5 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 40.4 Percentage of participants |
Secondary
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Percentage of subjects with any unsolicited AEs assessed in the QIVc group and in the comparator group until 28 days after each vaccination
Time frame: 28 days after each vaccination in the treatment period, ie, Day 1 to Day 29 for previously vaccinated subjects and Day 1 to Day 57 for not previously vaccinated subjects
Population: Unsolicited Safety Set, defined as all subjects in the All Exposed Set with unsolicited AE data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Any AE | 42.5 Percentage of participants |
| QIVc | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Any related AE | 4.2 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Any AE | 45.4 Percentage of participants |
| Comparator | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Any related AE | 3.6 Percentage of participants |