Human, Influenza
Conditions
Keywords
Influenza, Vaccine, MF59, Adjuvant
Brief summary
This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators) at 120 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serum.
Interventions
BIOLOGICALInvestigational aIIV4c
Investigational MF59 Adjuvanted Cell-derived 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.
BIOLOGICALIIV4c
Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
BIOLOGICALaIIV4
Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
BIOLOGICALRIV4
Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Individuals 50 years of age and older 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
1. Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so until 2 months after the study vaccination. 2. Progressive, unstable or uncontrolled clinical conditions. 3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. 4. History of any medical condition considered an adverse event of special interest. 5. Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis. 6. Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw. 7. Abnormal function of the immune system resulting from: 1. Clinical conditions 2. Systemic administration of corticosteroids (PO/IV/IM) at a dose of ≥ 20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent5. 3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. 8. Received immunoglobulins or any blood products within 180 days prior to informed consent. 9. Received an investigational or non-registered medicinal product within 30 days prior to vaccination. 10. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines. 11. Study personnel or immediate family or household member of study personnel. 12. Receipt of any influenza vaccine within 6 months prior to vaccination in this study, or plan to receive an influenza vaccine during the study period. 13. Acute (severe) febrile illness 14. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | 28 days post-vaccination | — |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | 28 days post-vaccination | — |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | 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 Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses | 28 days post-vaccination | — |
| Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | 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) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | 180 days post-vaccination | — |
| Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | 7 days post-vaccination | The percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination. |
| Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | 180 days post-vaccination | — |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | 180 days post-vaccination | — |
| Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | 180 days post-vaccination | — |
| Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | 180 days post-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) During the Entire Study Period | 180 days post-vaccination | — |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | 28 days post-vaccination | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational aIIV4c Group aIIV4c will be administered as a single dose intramuscularly on Day 1
Investigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived 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. | 116 |
| Licensed IIV4c Group IIV4c will be administered as a single dose intramuscularly on Day 1
IIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season. | 119 |
| Licensed aIIV4 Group aIIV4 will be administered as a single dose intramuscularly on Day 1
aIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season. | 116 |
| Licensed RIV4 Group RIV4 will be administered as a single dose intramuscularly on Day 1
RIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season. | 120 |
| Total | 471 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 3 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Investigational aIIV4c Group | Licensed IIV4c Group | Licensed aIIV4 Group | Licensed RIV4 Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 60 Participants | 62 Participants | 60 Participants | 62 Participants | 244 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 57 Participants | 56 Participants | 58 Participants | 227 Participants |
| Age, Continuous | 65.0 years STANDARD_DEVIATION 9.18 | 64.7 years STANDARD_DEVIATION 8.49 | 65.0 years STANDARD_DEVIATION 7.49 | 65.4 years STANDARD_DEVIATION 9.02 | 65.0 years STANDARD_DEVIATION 8.55 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 23 Participants | 15 Participants | 14 Participants | 15 Participants | 67 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 89 Participants | 100 Participants | 99 Participants | 105 Participants | 393 Participants |
| Region of Enrollment United States | 116 Participants | 119 Participants | 116 Participants | 120 Participants | 471 Participants |
| Sex: Female, Male Female | 69 Participants | 72 Participants | 71 Participants | 71 Participants | 283 Participants |
| Sex: Female, Male Male | 47 Participants | 47 Participants | 45 Participants | 49 Participants | 188 Participants |
| vaccinated within 3 previous influenza seasons no | 32 Participants | 34 Participants | 32 Participants | 35 Participants | 133 Participants |
| vaccinated within 3 previous influenza seasons yes | 84 Participants | 85 Participants | 84 Participants | 85 Participants | 338 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 116 | 0 / 119 | 0 / 116 | 0 / 120 |
| other Total, other adverse events | 86 / 116 | 77 / 119 | 84 / 116 | 83 / 120 |
| serious Total, serious adverse events | 2 / 116 | 1 / 119 | 4 / 116 | 6 / 120 |
Outcome results
Primary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Victoria HI GMR (aIIV4c/comparator group) | 1.36 Ratio |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H1N1 HI GMR (aIIV4c/comparator group) | 1.31 Ratio |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H3N2 MN GMR (aIIV4c/comparator group) | 1.18 Ratio |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Yamagata HI GMR (aIIV4c/comparator group) | 1.36 Ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Victoria HI GMR (aIIV4c/comparator group) | 1.81 Ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Yamagata HI GMR (aIIV4c/comparator group) | 1.85 Ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H1N1 HI GMR (aIIV4c/comparator group) | 1.22 Ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H3N2 MN GMR (aIIV4c/comparator group) | 1.31 Ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Yamagata HI GMR (aIIV4c/comparator group) | 1.15 Ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H1N1 HI GMR (aIIV4c/comparator group) | 0.84 Ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H3N2 MN GMR (aIIV4c/comparator group) | 0.79 Ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Victoria HI GMR (aIIV4c/comparator group) | 1.26 Ratio |
Primary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
Population: Per Protocol Set (PPS): All subjects in the Full Analysis Set (FAS) Immunogenicity who:~* Correctly received the vaccine (ie, received the vaccine to which the subject was randomized).~* Had no clinical study report (CSR)-reportable protocol deviation (PD) leading to exclusion (ie, impacting the results) as defined prior to unblinding.~* Had immunogenicity assessments within the window of +/- 7 days around the Day 29 visit, and Day 1 sample taken within 3 days before vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 1 HI GMT | 19.5 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 HI GMT | 146.05 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 1 HI GMT | 16.95 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 HI GMT | 69.35 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 1 HI GMT | 21.86 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 29 HI GMT | 94.82 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H3N2 Day 1 MN GMT | 71.44 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H3N2 Day 29 MN GMT | 138.88 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 29 HI GMT | 69.49 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 1 HI GMT | 22.02 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 HI GMT | 111.38 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H3N2 Day 29 MN GMT | 117.28 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H3N2 Day 1 MN GMT | 59.37 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 HI GMT | 50.99 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 1 HI GMT | 16.02 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 1 HI GMT | 17.04 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H3N2 Day 1 MN GMT | 60.20 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 1 HI GMT | 14.59 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 HI GMT | 37.51 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 1 HI GMT | 20.42 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 29 HI GMT | 52.35 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H3N2 Day 29 MN GMT | 106.22 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 1 HI GMT | 21.85 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 HI GMT | 119.54 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 1 HI GMT | 15.99 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 HI GMT | 60.25 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 HI GMT | 173.08 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 1 HI GMT | 18.05 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 1 HI GMT | 24.82 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H3N2 Day 29 MN GMT | 174.78 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | A/H3N2 Day 1 MN GMT | 64.93 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 29 HI GMT | 75.50 titer |
Primary
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H3N2 MN seroconversion Day 29 | 21.8 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Yamagata HI seroconversion Day 29 | 42.7 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H1N1 HI seroconversion Day 29 | 61.8 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Victoria HI seroconversion Day 29 | 46.4 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Yamagata HI seroconversion Day 29 | 31.6 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Victoria HI seroconversion Day 29 | 33.3 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H1N1 HI seroconversion Day 29 | 54.4 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H3N2 MN seroconversion Day 29 | 20.2 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H1N1 HI seroconversion Day 29 | 50.5 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Yamagata HI seroconversion Day 29 | 19.3 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Victoria HI seroconversion Day 29 | 26.6 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H3N2 MN seroconversion Day 29 | 9.2 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Yamagata HI seroconversion Day 29 | 37.9 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H1N1 HI seroconversion Day 29 | 61.2 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | A/H3N2 MN seroconversion Day 29 | 32.8 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses | B/Victoria HI seroconversion Day 29 | 40.5 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) Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 1 | 44.5 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 29 | 85.5 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata day 1 | 27.3 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata Day 29 | 81.8 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 1 | 32.7 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 29 | 90.0 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 29 | 72.8 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata Day 29 | 64.0 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 1 | 36.8 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata day 1 | 23.7 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 29 | 81.6 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 1 | 32.5 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 29 | 82.6 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata day 1 | 20.2 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata Day 29 | 52.3 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 29 | 69.7 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 1 | 30.3 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 1 | 41.3 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 1 | 38.8 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 29 | 79.3 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 29 | 84.5 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata Day 29 | 65.5 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 1 | 38.8 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata day 1 | 28.4 percentage of subjects |
Secondary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses
Time frame: 180 days post-vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 | 481.49 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H3N2 Day 181 | 68.72 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 | 24.46 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 181 | 31.68 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H3N2 Day 181 | 68.17 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 | 24.98 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 181 | 27.39 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 | 523.03 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 | 21.82 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H3N2 Day 181 | 54.35 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 181 | 24.97 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 | 502.85 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 181 | 34.09 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H3N2 Day 181 | 100.14 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 | 841.31 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 | 28.17 titer |
Secondary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses
Time frame: 180 days post-vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 | 156.47 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Victoria Day 181 | 103.64 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 | 34.70 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 | 144.08 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Victoria Day 181 | 94.16 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 | 33.26 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 | 23.56 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 | 157.72 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Victoria Day 181 | 67.78 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 | 198.17 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Victoria Day 181 | 74.54 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 | 32.04 titer |
Secondary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
Population: Per Protocol Set (PPS): All subjects in the FAS Immunogenicity who:~* Correctly received the vaccine (ie, received the vaccine to which the subject was randomized).~* 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 days around the Day 29 visit, and Day 1 sample taken within 3 days before vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | A/H1N1 Day 1 | 158.64 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 | 1261.77 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Yamagata Day 1 | 19.48 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 | 48.08 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Victoria Day 1 | 18.63 titer |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Victoria Day 29 | 58.47 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Victoria Day 29 | 47.63 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 | 42.89 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | A/H1N1 Day 1 | 102.88 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Yamagata Day 1 | 15.55 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 | 1036.72 titer |
| Licensed IIV4c Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Victoria Day 1 | 15.71 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 | 1050.54 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Yamagata Day 1 | 17.50 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 | 39.01 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Victoria Day 29 | 44.88 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Victoria Day 1 | 18.02 titer |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | A/H1N1 Day 1 | 162.19 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Victoria Day 1 | 18.02 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Victoria Day 29 | 61.8 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 | 1719.68 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 | 56.12 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | A/H1N1 Day 1 | 138.73 titer |
| Licensed RIV4 Group | Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses | B/Yamagata Day 1 | 17.62 titer |
Secondary
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses
Time frame: 180 days post-vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 day 181 MN GMR (aIIV4c/comparator group) | 0.92 ratio |
| Investigational aIIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H3N2 Day 181 MN GMR (aIIV4c/comparator group) | 1.01 ratio |
| Investigational aIIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 MN GMR (aIIV4c/comparator group) | 0.98 ratio |
| Investigational aIIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 181 MN GMR (aIIV4c/comparator group) | 1.16 ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 181 MN GMR (aIIV4c/comparator group) | 1.27 ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 day 181 MN GMR (aIIV4c/comparator group) | 0.96 ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 MN GMR (aIIV4c/comparator group) | 1.12 ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H3N2 Day 181 MN GMR (aIIV4c/comparator group) | 1.26 ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 181 MN GMR (aIIV4c/comparator group) | 0.93 ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H3N2 Day 181 MN GMR (aIIV4c/comparator group) | 0.69 ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 MN GMR (aIIV4c/comparator group) | 0.87 ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 day 181 MN GMR (aIIV4c/comparator group) | 0.57 ratio |
Secondary
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses
Time frame: 180 days post-vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 HI GMR (aIIV4c/comparator group) | 1.04 Ratio |
| Investigational aIIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 HI GMR (aIIV4c/comparator group) | 1.09 Ratio |
| Investigational aIIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Victoria Day 181 HI GMR (aIIV4c/comparator group) | 1.10 Ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 HI GMR (aIIV4c/comparator group) | 1.47 Ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 HI GMR (aIIV4c/comparator group) | 0.99 Ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Victoria Day 181 HI GMR (aIIV4c/comparator group) | 1.53 Ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | A/H1N1 Day 181 HI GMR (aIIV4c/comparator group) | 0.79 Ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Victoria Day 181 HI GMR (aIIV4c/comparator group) | 1.39 Ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses | B/Yamagata Day 181 HI GMR (aIIV4c/comparator group) | 1.08 Ratio |
Secondary
Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses
Time frame: 28 days post-vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 MN GMR (aIIV4c/comparator group) | 1.12 ratio |
| Investigational aIIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 MN GMR (aIIV4c/comparator group) | 1.22 ratio |
| Investigational aIIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 29 MN GMR (aIIV4c/comparator group) | 1.23 ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 MN GMR (aIIV4c/comparator group) | 1.23 ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 MN GMR (aIIV4c/comparator group) | 1.20 ratio |
| Licensed IIV4c Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 29 MN GMR (aIIV4c/comparator group) | 1.30 ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 MN GMR (aIIV4c/comparator group) | 0.73 ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses | B/Victoria Day 29 MN GMR (aIIV4c/comparator group) | 0.95 ratio |
| Licensed aIIV4 Group | Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 MN GMR (aIIV4c/comparator group) | 0.86 ratio |
Secondary
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 | 61.8 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 29 | 29.1 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 | 22.7 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 | 60.5 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 29 | 26.3 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 | 28.1 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 | 15.6 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 | 53.2 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 29 | 22.0 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | A/H1N1 Day 29 | 70.7 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | B/Victoria Day 29 | 37.1 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses | B/Yamagata Day 29 | 33.6 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) Using Cell-derived Target Viruses
Time frame: 180 days post-vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 181 | 88.9 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 181 | 93.5 percentage of subjects |
| Investigational aIIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata Day 181 | 50.0 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 181 | 87.3 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 181 | 91.8 percentage of subjects |
| Licensed IIV4c Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata Day 181 | 50.0 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata Day 181 | 32.7 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 181 | 87.3 percentage of subjects |
| Licensed aIIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 181 | 77.3 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | A/H1N1 Day 181 | 87.6 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Victoria Day 181 | 82.3 percentage of subjects |
| Licensed RIV4 Group | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses | B/Yamagata Day 181 | 52.2 percentage of subjects |
Secondary
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 FAS with any unsolicited AE data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Investigational aIIV4c Group | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 23 Participants |
| Investigational aIIV4c Group | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 1 Participants |
| Licensed IIV4c Group | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 1 Participants |
| Licensed IIV4c Group | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 27 Participants |
| Licensed aIIV4 Group | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 23 Participants |
| Licensed aIIV4 Group | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 3 Participants |
| Licensed RIV4 Group | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Unsolicited AE | 29 Participants |
| Licensed RIV4 Group | Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events | Any Related Unsolicited AE | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Investigational aIIV4c Group | 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 |
| Investigational aIIV4c Group | 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 |
| Investigational aIIV4c Group | 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 |
| Investigational aIIV4c Group | 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 |
| Investigational aIIV4c Group | 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 |
| Investigational aIIV4c Group | 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 Death | 1 Participants |
| Licensed IIV4c Group | 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 Death | 0 Participants |
| Licensed IIV4c Group | 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 |
| Licensed IIV4c Group | 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 |
| Licensed IIV4c Group | 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 |
| Licensed IIV4c Group | 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 |
| Licensed IIV4c Group | 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 |
| Licensed aIIV4 Group | 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 |
| Licensed aIIV4 Group | 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 |
| Licensed aIIV4 Group | 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 |
| Licensed aIIV4 Group | 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 Death | 0 Participants |
| Licensed aIIV4 Group | 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 |
| Licensed aIIV4 Group | 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 | 4 Participants |
| Licensed RIV4 Group | 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 |
| Licensed RIV4 Group | 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 Death | 0 Participants |
| Licensed RIV4 Group | 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 |
| Licensed RIV4 Group | 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 |
| Licensed RIV4 Group | 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 | 6 Participants |
| Licensed RIV4 Group | 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 |
Secondary
Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions
The 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 FAS with any solicited AE data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Investigational aIIV4c Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | solicited AEs | 85 Participants |
| Investigational aIIV4c Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | Solicited local AEs | 70 Participants |
| Investigational aIIV4c Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | Solicited systemic AEs | 69 Participants |
| Investigational aIIV4c Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | analgesic/antipyretic use | 18 Participants |
| Licensed IIV4c Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | Solicited local AEs | 52 Participants |
| Licensed IIV4c Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | analgesic/antipyretic use | 9 Participants |
| Licensed IIV4c Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | solicited AEs | 72 Participants |
| Licensed IIV4c Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | Solicited systemic AEs | 51 Participants |
| Licensed aIIV4 Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | solicited AEs | 83 Participants |
| Licensed aIIV4 Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | analgesic/antipyretic use | 11 Participants |
| Licensed aIIV4 Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | Solicited systemic AEs | 57 Participants |
| Licensed aIIV4 Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | Solicited local AEs | 67 Participants |
| Licensed RIV4 Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | analgesic/antipyretic use | 9 Participants |
| Licensed RIV4 Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | solicited AEs | 80 Participants |
| Licensed RIV4 Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | Solicited local AEs | 51 Participants |
| Licensed RIV4 Group | Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions | Solicited systemic AEs | 64 Participants |