| 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 | | 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.
| Posted | | Geometric Mean | 95% Confidence Interval | titer | | 28 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
| | Units | Counts |
|---|
| Participants | - OG000110
- OG001114
- OG002109
- OG003
|
| | Title | Denominators | Categories |
|---|
| A/H1N1 Day 1 HI GMT | | | Title | Measurements |
|---|
| - OG00019.5(15.5 to 24.5)
- OG00117.04(13.6 to 21.3)
- OG00221.85(17.4 to 27.5)
|
|
| |
| 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 | | | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | 28 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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 | | Posted | | Number | 95% Confidence Interval | percentage of subjects | | 28 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Licensed aIIV4 Group |
|
| 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 | | | Posted | | Number | 95% Confidence Interval | percentage of subjects | | 28 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Solicited Safety Set, defined as all subjects in the FAS with any solicited AE data. | Posted | | Count of Participants | | Participants | | 7 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Unsolicited Safety Set, defined as all subjects in the FAS with any unsolicited AE data | Posted | | Count of Participants | | Participants | | 28 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Licensed aIIV4 Group | |
|
| 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 | | | Posted | | Count of Participants | | Participants | | 180 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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 | | 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.
| Posted | | Geometric Mean | 95% Confidence Interval | titer | | 28 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | |
|
| 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 | | | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | 28 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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 | | Posted | | Number | 95% Confidence Interval | percentage of subjects | | 28 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Licensed aIIV4 Group |
|
| 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 | | | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 180 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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 | | | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | 180 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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 | | | Posted | | Number | 95% Confidence Interval | percentage of subjects | | 180 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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 | | | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 180 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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 | | | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | 180 days post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|