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Seasonal Influenza Vaccine · 7 trials · 4 indications
Antibody response to each influenza antigen as measured by hemagglutination inhibition (HI) at 21 days post-immunization in adult and elderly subjects in complinace with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines
Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase. The European (Committee for Medicinal Products for Human Use \[CHMP\]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years).
Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22). The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is \>2.0 (≥65 years).
Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22). This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years).
To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.
| Arm | Type | Description |
|---|---|---|
| cell culture derived TIV | EXPERIMENTAL | single dose of cell culture derived seasonal trivalent influenza vaccine (TIV) |
| 1 | EXPERIMENTAL | - |
| Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine | OTHER | No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit |
| Name | Type | Description |
|---|---|---|
| seasonal influenza vaccine | BIOLOGICAL | Subjects received one single IM dose of trivalent Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture during the vaccination visit, according to the study protocol (follow-up period: until day 22) . |
| Seasonal Influenza Vaccine (MF59C.1) | BIOLOGICAL | 1 dose of a surface antigen, inactivated, adjuvanted with MF59C.1, seasonal influenza vaccine, formulation 2009-2010 |
Inclusion Criteria: 1. Males and female volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry 2. Individuals able to comply with all the study requirements 3. Individuals in good health as determined by the outcome of medi...
Seasonal Influenza Vaccine is an investigational vaccine being developed for the prevention of influenza, including interpandemic and seasonal influenza. It is designed to provide immunity against circulating influenza virus strains and is intended for use in adults, including the elderly.
Seasonal Influenza Vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in clinical development for the prevention of seasonal influenza.
Seasonal Influenza Vaccine is in Phase 3 clinical development. It has completed multiple clinical trials, including Phase 2 and Phase 3 studies, but it remains investigational and has not yet been approved by regulatory authorities. The vaccine is still undergoing evaluation for safety and immunogenicity.
Seasonal Influenza Vaccine has been studied in several completed clinical trials, including NCT00735410, a Phase 3 study in Germany, and NCT01422512, another Phase 3 trial in Germany. Additional Phase 2 trials include NCT00956449 in the United Kingdom and NCT01357265 in Italy. All trials enrolled healthy adults aged 18 years and older.
Seasonal Influenza Vaccine is a vaccine that works by stimulating the immune system to produce antibodies against influenza virus surface antigens. It contains inactivated or split influenza virus components that mimic the circulating strains, preparing the body to fight off infection upon exposure to the actual virus.