Influenza
Conditions
Brief summary
This Phase 2, randomized, observer-blind, antigen and adjuvant dose-ranging Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 800 subjects are to be randomized into 1 of 8 possible treatment groups. Immunogenicity and safety will be assessed in the overall study population (adults ≥50 years and above) and in the age subgroups ≥50-64 years and ≥65 years. Data from this study will be used to select the optimal dose to be tested in the pivotal Phase 3 immunogenicity and safety study in older adults. Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded.
Interventions
DRUGaQII-1
Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
DRUGaQII-3 Investigational
Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
DRUGaQII-6 Investigational
Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OTHERaQII-7 Investigational
Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
DRUGaQII-9 Investigational
Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
DRUGaQII-10 Investigational
Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
DRUGaQII-11 Investigational
Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
DRUGLicensed QII Active Comparator
Biological/Vaccine: Licensed QII Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 1. Individuals ≥50 years of age on the day of informed consent. 2. 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. 3. Individuals who can comply with study procedures including follow-up . 4. 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: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | [28 days post-vaccination] | — |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | 28 days post-vaccination | — |
| Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | 28 days post-vaccination | Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers |
| Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | 28 days post-vaccination | — |
| Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | 7 days post-vaccination | Percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination |
| Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | 28 days post-vaccination | The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29. Related AEs = considered at least possibly related to study vaccination by the investigator |
| Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | 28 days post-vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | 180 days post-vaccination | — |
| Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | 180 days post-vaccination | — |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | 180 days post-vaccination | — |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | 28 days post-vaccination | — |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | 28 days post-vaccination | — |
| Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | 28 days post-vaccination | Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | 180 days post-vaccination | — |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | 180 days post-vaccination | — |
| Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | 180 days post-vaccination | — |
Countries
Australia, New Zealand, Philippines, South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group H Licensed QII Active Comparator Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season. | 98 |
| Group A aQII-1 Investigational aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season. | 107 |
| Group E aQII-9 Investigational aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season. | 107 |
| Group C aQII-6 Investigational aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season. | 103 |
| Group F aQII-10 Investigational aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season. | 106 |
| Group B aQII-3 Investigational aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season. | 108 |
| Group D aQII-7 Investigational aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season. | 101 |
| Group G aQII-11 Investigational aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season. | 109 |
| Total | 839 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 2 |
| Overall Study | randomization in error | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Group A aQII-1 Investigational | Group E aQII-9 Investigational | Group C aQII-6 Investigational | Group F aQII-10 Investigational | Group H Licensed QII Active Comparator | Group B aQII-3 Investigational | Group D aQII-7 Investigational | Group G aQII-11 Investigational | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 52 Participants | 54 Participants | 51 Participants | 48 Participants | 46 Participants | 50 Participants | 47 Participants | 49 Participants | 397 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 53 Participants | 52 Participants | 58 Participants | 52 Participants | 58 Participants | 54 Participants | 60 Participants | 442 Participants |
| Age, Continuous | 63.6 years STANDARD_DEVIATION 8.91 | 63.6 years STANDARD_DEVIATION 8.1 | 63.3 years STANDARD_DEVIATION 8.48 | 62.8 years STANDARD_DEVIATION 8.22 | 63.4 years STANDARD_DEVIATION 7.68 | 63.5 years STANDARD_DEVIATION 8.82 | 64.4 years STANDARD_DEVIATION 9.12 | 63.1 years STANDARD_DEVIATION 8.5 | 63.5 years STANDARD_DEVIATION 8.47 |
| Race/Ethnicity, Customized asian | 14 Participants | 22 Participants | 20 Participants | 18 Participants | 21 Participants | 18 Participants | 16 Participants | 18 Participants | 147 Participants |
| Race/Ethnicity, Customized black or african american | 16 Participants | 15 Participants | 11 Participants | 15 Participants | 11 Participants | 13 Participants | 13 Participants | 17 Participants | 111 Participants |
| Race/Ethnicity, Customized native hawaiian or other pacific islander | 2 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants | 1 Participants | 15 Participants |
| Race/Ethnicity, Customized other | 9 Participants | 16 Participants | 13 Participants | 12 Participants | 10 Participants | 17 Participants | 10 Participants | 10 Participants | 97 Participants |
| Race/Ethnicity, Customized white | 66 Participants | 51 Participants | 56 Participants | 61 Participants | 56 Participants | 58 Participants | 58 Participants | 63 Participants | 469 Participants |
| Region of Enrollment Australia | 37 participants | 38 participants | 36 participants | 38 participants | 36 participants | 38 participants | 40 participants | 40 participants | 303 participants |
| Region of Enrollment New Zealand | 32 participants | 32 participants | 30 participants | 30 participants | 29 participants | 33 participants | 29 participants | 31 participants | 246 participants |
| Region of Enrollment Philippines | 11 participants | 16 participants | 17 participants | 12 participants | 15 participants | 13 participants | 12 participants | 13 participants | 109 participants |
| Region of Enrollment South Africa | 27 participants | 21 participants | 20 participants | 26 participants | 18 participants | 24 participants | 20 participants | 25 participants | 181 participants |
| Sex: Female, Male Female | 62 Participants | 63 Participants | 63 Participants | 57 Participants | 69 Participants | 49 Participants | 53 Participants | 59 Participants | 475 Participants |
| Sex: Female, Male Male | 45 Participants | 44 Participants | 40 Participants | 49 Participants | 29 Participants | 59 Participants | 48 Participants | 50 Participants | 364 Participants |
| vaccinated within 3 previous influenza season No | 41 Participants | 46 Participants | 35 Participants | 44 Participants | 38 Participants | 43 Participants | 40 Participants | 46 Participants | 333 Participants |
| vaccinated within 3 previous influenza season Yes | 66 Participants | 61 Participants | 68 Participants | 62 Participants | 60 Participants | 65 Participants | 61 Participants | 63 Participants | 506 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 97 | 0 / 107 | 0 / 108 | 0 / 103 | 1 / 106 | 1 / 107 | 1 / 101 | 0 / 109 |
| other Total, other adverse events | 55 / 97 | 74 / 107 | 80 / 108 | 79 / 103 | 91 / 106 | 81 / 107 | 72 / 101 | 89 / 109 |
| serious Total, serious adverse events | 8 / 97 | 1 / 107 | 1 / 108 | 3 / 103 | 5 / 106 | 3 / 107 | 2 / 101 | 2 / 109 |
Outcome results
Primary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay
Time frame: 28 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H1N1 HI GMR (aQII/QII) | 0.77 Ratio |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Yamagata HI GMR (aQII/QII) | 0.99 Ratio |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Victoria HI GMR (aQII/QII) | 1.01 Ratio |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H3N2 MN GMR (aQII/QII) | 0.97 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H3N2 MN GMR (aQII/QII) | 1.22 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Victoria HI GMR (aQII/QII) | 0.95 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H1N1 HI GMR (aQII/QII) | 0.88 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Yamagata HI GMR (aQII/QII) | 1.25 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Victoria HI GMR (aQII/QII) | 0.98 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Yamagata HI GMR (aQII/QII) | 1.31 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H1N1 HI GMR (aQII/QII) | 0.99 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H3N2 MN GMR (aQII/QII) | 1.26 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H1N1 HI GMR (aQII/QII) | 0.98 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Yamagata HI GMR (aQII/QII) | 1.29 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Victoria HI GMR (aQII/QII) | 1.23 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H3N2 MN GMR (aQII/QII) | 1.32 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H1N1 HI GMR (aQII/QII) | 1.07 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H3N2 MN GMR (aQII/QII) | 1.29 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Yamagata HI GMR (aQII/QII) | 1.32 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Victoria HI GMR (aQII/QII) | 1.11 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Yamagata HI GMR (aQII/QII) | 1.43 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H1N1 HI GMR (aQII/QII) | 1.19 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Victoria HI GMR (aQII/QII) | 1.25 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H3N2 MN GMR (aQII/QII) | 1.35 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Victoria HI GMR (aQII/QII) | 1.28 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H1N1 HI GMR (aQII/QII) | 0.97 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | B/Yamagata HI GMR (aQII/QII) | 1.45 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay | A/H3N2 MN GMR (aQII/QII) | 1.08 Ratio |
Primary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
Time frame: [28 days post-vaccination]
Population: Per Protocol Set (PPS) Immunogenicity: All subjects in the FAS Immunogenicity who~* Correctly received the vaccine (ie, received the vaccine to which the subject was randomized within the defined window).~* Had no CSR-reportable PD leading to exclusion (ie, impacting the results) as defined prior to unblinding.~* Had immunogenicity assessments within the window of -7/+21 days around the Day 29 visit, and Day 1 sample taken.~* Were not excluded due to other reason defined prior to unblinding.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 1 HI GMT | 15.02 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 29 HI GMT | 228.11 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 1 HI GMT | 42.31 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 29 HI GMT | 47.73 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 1 HI GMT | 58.85 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 29 HI GMT | 145.12 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 1 MN GMT | 35.31 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 29 MN GMT | 146.59 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 1 HI GMT | 74.31 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 1 HI GMT | 16.7 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 29 HI GMT | 146.85 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 1 MN GMT | 31.61 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 1 HI GMT | 40.39 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 29 HI GMT | 47.46 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 29 HI GMT | 175.95 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 29 MN GMT | 142.04 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 1 MN GMT | 32.05 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 1 HI GMT | 65.27 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 29 MN GMT | 178.87 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 1 HI GMT | 20.83 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 29 HI GMT | 138.29 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 29 HI GMT | 59.74 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 1 HI GMT | 48.29 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 29 HI GMT | 200.22 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 29 MN GMT | 185.07 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 29 HI GMT | 225.66 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 1 HI GMT | 49.31 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 29 HI GMT | 62.34 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 1 HI GMT | 18.35 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 1 HI GMT | 68.00 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 29 HI GMT | 141.84 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 1 MN GMT | 32.48 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 29 HI GMT | 61.36 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 1 MN GMT | 36.83 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 1 HI GMT | 15.51 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 1 HI GMT | 46.19 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 29 MN GMT | 193.02 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 1 HI GMT | 62.26 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 29 HI GMT | 178.15 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 29 HI GMT | 223.37 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 29 MN GMT | 189.17 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 29 HI GMT | 243.16 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 1 HI GMT | 16.41 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 1 HI GMT | 47.50 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 1 MN GMT | 32.71 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 29 HI GMT | 160.54 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 1 HI GMT | 63.72 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 29 HI GMT | 63.21 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 1 HI GMT | 17.13 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 29 HI GMT | 270.55 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 29 HI GMT | 68.14 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 1 HI GMT | 79.15 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 29 HI GMT | 181.93 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 29 MN GMT | 197.27 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 1 MN GMT | 30.80 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 1 HI GMT | 46.92 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 29 MN GMT | 157.90 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 29 HI GMT | 186.06 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Victoria Day 1 HI GMT | 64.13 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 29 HI GMT | 69.13 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | B/Yamagata Day 1 HI GMT | 16.00 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 29 HI GMT | 220.29 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H1N1 Day 1 HI GMT | 37.24 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay | A/H3N2 Day 1 MN GMT | 27.15 titer |
Primary
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
Time frame: 28 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H1N1 HI seroconversion Day 29 | 55.8 percentage of subjects |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Yamagata HI seroconversion Day 29 | 35.8 percentage of subjects |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Victoria HI seroconversion Day 29 | 32.6 percentage of subjects |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H3N2 MN seroconversion Day 29 | 53.7 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Victoria HI seroconversion Day 29 | 25.7 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H1N1 HI seroconversion Day 29 | 53.3 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H3N2 MN seroconversion Day 29 | 54.3 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Yamagata HI seroconversion Day 29 | 35.2 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H3N2 MN seroconversion Day 29 | 67.0 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Victoria HI seroconversion Day 29 | 22.6 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Yamagata HI seroconversion Day 29 | 42.5 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H1N1 HI seroconversion Day 29 | 51.9 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Victoria HI seroconversion Day 29 | 26.3 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H3N2 MN seroconversion Day 29 | 62.6 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Yamagata HI seroconversion Day 29 | 46.5 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H1N1 HI seroconversion Day 29 | 54.5 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Victoria HI seroconversion Day 29 | 35.3 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H1N1 HI seroconversion Day 29 | 57.8 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Yamagata HI seroconversion Day 29 | 41.2 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H3N2 MN seroconversion Day 29 | 59.8 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Victoria HI seroconversion Day 29 | 38.5 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H3N2 MN seroconversion Day 29 | 62.5 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H1N1 HI seroconversion Day 29 | 58.7 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Yamagata HI seroconversion Day 29 | 46.2 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Yamagata HI seroconversion Day 29 | 48.4 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H3N2 MN seroconversion Day 29 | 71.6 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H1N1 HI seroconversion Day 29 | 60.0 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Victoria HI seroconversion Day 29 | 34.7 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Victoria HI seroconversion Day 29 | 34.6 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H3N2 MN seroconversion Day 29 | 65.4 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | A/H1N1 HI seroconversion Day 29 | 57.7 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay | B/Yamagata HI seroconversion Day 29 | 51.0 percentage of subjects |
Primary
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
Time frame: 28 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 29 | 94.7 percentage of subjects |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 1 | 66.3 percentage of subjects |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 29 | 95.8 percentage of subjects |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 1 | 22.1 percentage of subjects |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 1 | 72.6 percentage of subjects |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 29 | 74.7 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 1 | 29.5 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 1 | 60.0 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 29 | 68.6 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 29 | 92.4 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 29 | 94.3 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 1 | 78.1 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 1 | 81.1 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 1 | 34.9 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 29 | 96.2 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 29 | 78.3 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 29 | 95.3 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 1 | 67.9 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 1 | 79.8 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 1 | 71.7 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 29 | 93.9 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 1 | 28.3 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 29 | 84.8 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 29 | 94.9 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 1 | 71.6 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 29 | 92.2 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 29 | 97.1 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 1 | 68.6 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 29 | 77.5 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 1 | 22.5 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 1 | 25.0 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 29 | 75.0 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 29 | 95.2 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 1 | 76.0 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 1 | 66.3 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 29 | 97.1 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 29 | 80.0 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 1 | 78.9 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 1 | 66.3 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 1 | 27.4 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 29 | 94.7 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 29 | 98.9 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 29 | 79.8 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata day 1 | 26.9 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 29 | 98.1 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 1 | 74.0 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 1 | 51.0 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 29 | 90.4 percentage of subjects |
Primary
Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
Percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination
Time frame: 7 days post-vaccination
Population: Solicited Safety Set, defined as all subjects in the Exposed Set with any solicited AE data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | solicited AEs | 44 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited systemic AEs | 34 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited local AEs | 29 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited systemic AEs | 48 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited local AEs | 55 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | solicited AEs | 69 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited systemic AEs | 49 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | solicited AEs | 71 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited local AEs | 63 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | solicited AEs | 76 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited local AEs | 68 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited systemic AEs | 59 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited local AEs | 72 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | solicited AEs | 85 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited systemic AEs | 66 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited local AEs | 57 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | solicited AEs | 73 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited systemic AEs | 52 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited local AEs | 55 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | solicited AEs | 60 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited systemic AEs | 46 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | solicited AEs | 82 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited local AEs | 73 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions | Solicited systemic AEs | 64 Participants |
Primary
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29. Related AEs = considered at least possibly related to study vaccination by the investigator
Time frame: 28 days post-vaccination
Population: Unsolicited Safety Set, defined as all subjects in the Exposed Set with any unsolicited AE data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 29 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 9 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 27 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 7 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 26 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 11 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 30 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 14 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 32 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 15 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 26 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 9 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 6 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 30 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 30 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 16 Participants |
Primary
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
Time frame: 28 days post-vaccination
Population: Unsolicited Safety Set, defined as all subjects in the Exposed Set with any unsolicited AE data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Serious Unsolicited AE | 4 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any deaths | 1 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE Leading to Withdrawal from the Study | 1 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Medically Attended AE | 13 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE of Special Interest | 1 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE of Special Interest | 0 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any deaths | 0 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Medically Attended AE | 5 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Serious Unsolicited AE | 0 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE of Special Interest | 0 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any deaths | 0 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Serious Unsolicited AE | 1 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Medically Attended AE | 5 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Medically Attended AE | 8 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any deaths | 0 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Serious Unsolicited AE | 1 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE of Special Interest | 0 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Medically Attended AE | 4 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Serious Unsolicited AE | 0 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE of Special Interest | 0 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any deaths | 0 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Medically Attended AE | 9 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE of Special Interest | 0 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Serious Unsolicited AE | 0 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any deaths | 0 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Medically Attended AE | 9 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Serious Unsolicited AE | 0 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE of Special Interest | 0 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any deaths | 0 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any deaths | 0 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Serious Unsolicited AE | 0 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Medically Attended AE | 7 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) | Any Unsolicited AE of Special Interest | 0 Participants |
Secondary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
Time frame: 180 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 (aQII/QII) | 1.03 Ratio |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 (aQII/QII) | 0.96 Ratio |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 (aQII/QII) | 1.01 Ratio |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 (aQII/QII) | 1.03 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 (aQII/QII) | 1.20 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 (aQII/QII) | 1.09 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 (aQII/QII) | 0.83 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 (aQII/QII) | 1.01 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 (aQII/QII) | 1.20 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 (aQII/QII) | 1.24 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 (aQII/QII) | 1.19 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 (aQII/QII) | 1.40 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 (aQII/QII) | 1.09 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 (aQII/QII) | 1.13 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 (aQII/QII) | 1.19 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 (aQII/QII) | 1.36 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 (aQII/QII) | 1.01 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 (aQII/QII) | 1.14 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 (aQII/QII) | 1.15 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 (aQII/QII) | 1.06 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 (aQII/QII) | 1.22 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 (aQII/QII) | 1.25 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 (aQII/QII) | 1.18 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 (aQII/QII) | 1.64 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 (aQII/QII) | 1.23 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 (aQII/QII) | 0.96 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 (aQII/QII) | 0.86 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 (aQII/QII) | 1.25 Ratio |
Secondary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
Time frame: 180 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 (aQII/QII) | 0.96 Ratio |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 (aQII/QII) | 1.06 Ratio |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 (aQII/QII) | 0.86 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 (aQII/QII) | 1.07 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 (aQII/QII) | 0.71 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 (aQII/QII) | 1.07 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 (aQII/QII) | 1.01 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 (aQII/QII) | 0.78 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 (aQII/QII) | 0.99 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 (aQII/QII) | 1.02 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 (aQII/QII) | 0.84 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 (aQII/QII) | 1.03 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 (aQII/QII) | 0.99 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 (aQII/QII) | 0.71 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 (aQII/QII) | 1.01 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 (aQII/QII) | 0.77 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 (aQII/QII) | 1.23 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 (aQII/QII) | 1.08 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 (aQII/QII) | 1.05 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 (aQII/QII) | 1.09 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 (aQII/QII) | 0.78 Ratio |
Secondary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay
Time frame: 28 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Victoria GMR (aQII/QII) | 1.05 Ratio |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Yamagata GMR (aQII/QII) | 0.99 Ratio |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | A/H1N1 GMR (aQII/QII) | 1.04 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Yamagata GMR (aQII/QII) | 1.30 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | A/H1N1 GMR (aQII/QII) | 0.90 Ratio |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Victoria GMR (aQII/QII) | 1.40 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Victoria GMR (aQII/QII) | 1.49 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | A/H1N1 GMR (aQII/QII) | 1.25 Ratio |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Yamagata GMR (aQII/QII) | 1.24 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Yamagata GMR (aQII/QII) | 1.35 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | A/H1N1 GMR (aQII/QII) | 1.39 Ratio |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Victoria GMR (aQII/QII) | 1.54 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Yamagata GMR (aQII/QII) | 1.18 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | A/H1N1 GMR (aQII/QII) | 1.33 Ratio |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Victoria GMR (aQII/QII) | 1.35 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | A/H1N1 GMR (aQII/QII) | 1.53 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Victoria GMR (aQII/QII) | 1.43 Ratio |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Yamagata GMR (aQII/QII) | 1.25 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Victoria GMR (aQII/QII) | 1.30 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | B/Yamagata GMR (aQII/QII) | 1.21 Ratio |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay | A/H1N1 GMR (aQII/QII) | 0.98 Ratio |
Secondary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
Time frame: 180 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 | 516.06 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 | 73.72 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 | 26.19 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 | 175.30 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 | 180.26 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 | 70.50 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 | 529.64 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 | 26.38 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 | 427.95 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 | 209.57 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 | 74.71 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 | 28.53 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 | 615.44 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 | 91.77 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 | 31.48 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 | 246.04 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 | 238.56 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 | 31.3 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 | 83.3 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 | 562.64 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 | 199.67 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 | 27.82 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 | 85.11 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 | 518.67 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 | 286.95 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 | 644.81 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 | 30.96 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 | 90.00 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H3N2 Day 181 | 63.44 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Yamagata Day 181 | 32.20 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | B/Victoria Day 181 | 218.44 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay | A/H1N1 Day 181 | 493.66 titer |
Secondary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
Time frame: 180 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 | 110.69 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 | 55.42 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 | 25.05 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 | 53.30 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 | 26.58 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 | 95.07 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 | 59.26 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 | 78.87 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 | 26.71 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 | 86.67 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 | 24.89 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 | 56.00 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 | 25.52 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 | 92.45 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 | 56.97 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 | 24.73 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 | 78.23 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 | 55.86 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 | 27.00 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 | 85.50 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 | 68.07 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | A/H1N1 Day 181 | 86.67 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Yamagata Day 181 | 27.33 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay | B/Victoria Day 181 | 57.94 titer |
Secondary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
Time frame: 28 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 1 | 44.55 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 1 | 14.80 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 29 | 43.60 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 1 | 35.10 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 29 | 476.69 titer |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 29 | 112.86 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 1 | 15.53 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 1 | 29.77 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 1 | 43.96 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 29 | 117.97 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 29 | 43.1 titer |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 29 | 495.34 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 29 | 56.7 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 1 | 31.77 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 1 | 18.04 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 29 | 430.24 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 29 | 157.54 titer |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 1 | 38.15 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 29 | 54.23 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 1 | 18.01 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 29 | 596.45 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 1 | 41.08 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 29 | 168.62 titer |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 1 | 39.02 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 29 | 173.89 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 1 | 16.05 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 1 | 32.29 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 1 | 39.86 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 29 | 58.79 titer |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 29 | 660.96 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 29 | 51.38 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 1 | 44.56 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 1 | 15.84 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 29 | 634.42 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 29 | 152.41 titer |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 1 | 32.99 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 29 | 161.86 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 1 | 30.44 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 1 | 38.07 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 1 | 14.92 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 29 | 54.7 titer |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 29 | 730.30 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 1 | 34.77 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Victoria Day 29 | 146.56 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 29 | 465.89 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 1 | 14.63 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | A/H1N1 Day 1 | 32.49 titer |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay | B/Yamagata Day 29 | 52.65 titer |
Secondary
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
Time frame: 28 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | A/H1N1 Day 29 | 73.7 percentage of subjects |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Victoria Day 29 | 37.9 percentage of subjects |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Yamagata Day 29 | 31.6 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Victoria Day 29 | 35.2 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Yamagata Day 29 | 27.6 percentage of subjects |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | A/H1N1 Day 29 | 82.9 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Victoria Day 29 | 48.1 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | A/H1N1 Day 29 | 82.1 percentage of subjects |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Yamagata Day 29 | 39.6 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | A/H1N1 Day 29 | 79.8 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Yamagata Day 29 | 38.4 percentage of subjects |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Victoria Day 29 | 44.4 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Yamagata Day 29 | 45.1 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | A/H1N1 Day 29 | 87.3 percentage of subjects |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Victoria Day 29 | 50.0 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Yamagata Day 29 | 37.5 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | A/H1N1 Day 29 | 83.7 percentage of subjects |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Victoria Day 29 | 42.3 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Yamagata Day 29 | 40.0 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | A/H1N1 Day 29 | 87.4 percentage of subjects |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Victoria Day 29 | 45.3 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | A/H1N1 Day 29 | 87.5 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Yamagata Day 29 | 42.3 percentage of subjects |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay | B/Victoria Day 29 | 42.3 percentage of subjects |
Secondary
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
Time frame: 180 days post-vaccination
Population: The analysis population is PPS Immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 181 | 71.3 percentage |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata Day 181 | 42.6 percentage |
| Group H Licensed QII Active Comparator | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 181 | 87.2 percentage |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 181 | 75.5 percentage |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata Day 181 | 42.5 percentage |
| Group A aQII-1 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 181 | 85.8 percentage |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata Day 181 | 49.5 percentage |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 181 | 80.0 percentage |
| Group E aQII-9 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 181 | 74.3 percentage |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata Day 181 | 44.4 percentage |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 181 | 82.8 percentage |
| Group C aQII-6 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 181 | 71.7 percentage |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata Day 181 | 40.2 percentage |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 181 | 72.5 percentage |
| Group F aQII-10 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 181 | 87.3 percentage |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata Day 181 | 40.2 percentage |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 181 | 74.2 percentage |
| Group B aQII-3 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 181 | 80.4 percentage |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 181 | 83.0 percentage |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata Day 181 | 44.7 percentage |
| Group D aQII-7 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 181 | 73.4 percentage |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Yamagata Day 181 | 44.1 percentage |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | A/H1N1 Day 181 | 81.4 percentage |
| Group G aQII-11 Investigational | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) | B/Victoria Day 181 | 71.6 percentage |
Secondary
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Time frame: 180 days post-vaccination
Population: Unsolicited Safety Set, defined as all subjects in the Exposed Set with any unsolicited AE data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Deaths | 1 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Serious Unsolicited AE | 8 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Related Serious Unsolicited AE | 0 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE of Special Interest | 1 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE Leading to Withdrawal from the Study | 1 Participants |
| Group H Licensed QII Active Comparator | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Medically Attended AE | 20 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE of Special Interest | 0 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Serious Unsolicited AE | 1 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Medically Attended AE | 15 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Deaths | 0 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Related Serious Unsolicited AE | 0 Participants |
| Group A aQII-1 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE of Special Interest | 0 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Related Serious Unsolicited AE | 0 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Medically Attended AE | 13 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Deaths | 0 Participants |
| Group E aQII-9 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Serious Unsolicited AE | 1 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Serious Unsolicited AE | 3 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Related Serious Unsolicited AE | 0 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE of Special Interest | 0 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Medically Attended AE | 18 Participants |
| Group C aQII-6 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Deaths | 0 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE Leading to Withdrawal from the Study | 1 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Related Serious Unsolicited AE | 1 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Deaths | 1 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Serious Unsolicited AE | 5 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Medically Attended AE | 14 Participants |
| Group F aQII-10 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE of Special Interest | 2 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE of Special Interest | 0 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Medically Attended AE | 21 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Related Serious Unsolicited AE | 0 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE Leading to Withdrawal from the Study | 1 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Serious Unsolicited AE | 3 Participants |
| Group B aQII-3 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Deaths | 1 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Medically Attended AE | 20 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE Leading to Withdrawal from the Study | 1 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Serious Unsolicited AE | 2 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE of Special Interest | 0 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Deaths | 1 Participants |
| Group D aQII-7 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Related Serious Unsolicited AE | 0 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Medically Attended AE | 16 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE of Special Interest | 0 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Deaths | 0 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Unsolicited AE Leading to Withdrawal from the Study | 0 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Serious Unsolicited AE | 2 Participants |
| Group G aQII-11 Investigational | Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period | Any Related Serious Unsolicited AE | 0 Participants |