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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...
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It is an investigational influenza vaccine developed by Novartis AG. It is a cell-derived, subunit, trivalent, nonadjuvanted vaccine designed to protect against influenza. It has been studied in a Phase 3 clinical trial in adults aged 18 years and above. It is not approved and remains in clinical development.
It is being developed for the prevention of influenza. The vaccine targets influenza infection in adults aged 18 years and older. Its only recorded clinical trial enrolled 126 participants in Germany. The vaccine is investigational and has not been approved for use.
Novartis AG, which trades under the ticker NVS, is the developer of the cell derived subunit trivalent nonadjuvanted vaccine. The company sponsored the Phase 3 trial of the vaccine. No other developer or partner is listed for this asset.
The cell derived subunit trivalent nonadjuvanted vaccine is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA or any other regulatory agency.
The cell derived subunit trivalent nonadjuvanted vaccine has been studied in one clinical trial, NCT01640314. That Phase 3 trial was titled "Safety and Immunogenicity of a Cell Derived Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above." It was completed, enrolled 126 participants, and was conducted in Germany.
No. The Phase 3 trial NCT01640314 for the cell derived subunit trivalent nonadjuvanted vaccine was not randomized and was not double-blind. It used an uncontrolled design. The trial enrolled 126 healthy adult volunteers aged 18 years and above in Germany and has been completed.