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Cell derived subunit trivalent nonadjuvanted vaccine · 1 trial · 1 indication
Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI cell-derived antigen assay. As per the European (CHMP) criteria, seroconversion or significant increase in titer is defined as the percentage of subjects with a prevaccination HI titer \<10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. This criterion is met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is \>40% (≥18 years to ≤60 years) or 30% (≥61 years).
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22). The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer is \>2.5 (≥18 years to ≤60 years) or \>2.0 (≥61 years).
Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVc vaccination (day 22). This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is \>70% (≥18 years to ≤60) or 60% (≥61 years).
| Arm | Type | Description |
|---|---|---|
| Cell derived subunit trivalent nonadjuvanted vaccine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cell derived subunit trivalent nonadjuvanted vaccine | BIOLOGICAL | A single 0.5 mL dose of the cell derived subunit trivalent nonadjuvated influenza vaccine (TIVc) supplied in prefilled syringes and administered intramuscularly in the deltoid muscle (preferably) of the non dominant arm. |
Inclusion Criteria: 1. Male and female volunteers of 18 years of age or older; 2. Individuals able to comply with all the study requirements; 3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. Exclusion Cri...