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Trivalent influenza virus vaccine · 3 trials · 4 indications
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 antigen assay. As per the European (CHMP) criteria seroconversion or significant increase in titer was 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 was 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 was \>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 TIVf 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).
To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 pandemic influenza vaccine (aH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 6 days after each vaccination per vaccination group.
To report safety data from a large enough number of subjects exposed to adjuvanted pandemic influenza vaccine aH5N1 capable of detecting rare adverse events (AEs), i.e. events occurring at a frequency of \<=0.1%, \& uncommon AEs in elderly, i.e. occurring at a frequency of \<=1% of subjects.
Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area 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 SRH geometric mean areas (GMAs), 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 SRH antibody area is \>2.5 (≥18 years to ≤60 years) or \>2.0 (≥61 years).
Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after TIV vaccination (day 22). This criterion was met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is \>70% (≥18 years to ≤60) or 60% (≥61 years).
| Arm | Type | Description |
|---|---|---|
| TIVf | EXPERIMENTAL | - |
| TIV + aH5N1 | EXPERIMENTAL | First dose of the non-adjuvanted trivalent influenza virus vaccine (TIV) followed by two doses of the adjuvanted monovalent influenza virus vaccine (aH5N1). |
| PL + aTIV | ACTIVE_COMPARATOR | First dose of placebo (PL-saline) followed by two doses of the adjuvanted trivalent influenza virus vaccine (aTIV). |
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Trivalent influenza virus vaccine (TIVf) | BIOLOGICAL | A single dose (0.5 mL) of vaccine supplied in prefilled syringes was administered intramuscularly in the deltoid muscle, preferably of the non dominant arm |
| Placebo (PL) | BIOLOGICAL | One dose of 0.5 ml IM injection of isotonic saline solution was administered in the deltoid muscle, preferably of the non-dominant arm. |
| Trivalent influenza virus vaccine (TIV) | BIOLOGICAL | A single IM injection of a 0.5 ml dose of non-adjuvanted trivalent influenza virus vaccine administered in the deltoid muscle, preferably of the non-dominant arm. |
| Adjuvanted monovalent influenza virus vaccine (aH5N1) | BIOLOGICAL | Two intramuscular (IM) injections of a 0.5 ml dose administered three weeks apart in the deltoid muscle. |
| Adjuvanted trivalent influenza virus vaccine (aTIV) | BIOLOGICAL | Two IM injections of a 0.5 ml dose of adjuvanted trivalent influenza virus vaccine administered three weeks apart, in the deltoid muscle. |
Inclusion Criteria: 1. Male and female volunteers of 18 years of age or older, mentally competent, were willing and gave written informed consent prior to study entry; 2. Individuals who complied with all the study requirements; 3. Individuals in good health as determined by the outcome of medical ...
Trivalent influenza virus vaccine is used for pandemic influenza disease and human influenza. It is an investigational vaccine being developed by Novartis AG (NVS) for the prevention of influenza. The vaccine is currently in Phase 3 clinical development, with completed trials evaluating its safety, tolerability, and immunogenicity in adult and elderly populations.
Trivalent influenza virus vaccine is being developed by Novartis AG, which trades under the ticker NVS. The company has conducted clinical trials for this vaccine in countries including Finland, Germany, and Belgium, focusing on healthy adult and elderly subjects to assess its safety and immunogenicity.
Trivalent influenza virus vaccine is in Phase 3 clinical development. It has completed Phase 3 trials, including a study with 3,647 participants evaluating two doses of an adjuvanted monovalent influenza vaccine for pandemic influenza. The vaccine remains investigational and is not yet approved for commercial use.
Trivalent influenza virus vaccine has been studied in several completed trials. NCT00841763 was a Phase 3 trial with 3,647 participants in Finland and Germany for pandemic influenza. NCT01636102 was a Phase 2 trial with 126 participants in Belgium, and NCT01640327 was a Phase 3 trial with 126 participants in Germany for human influenza.
Trivalent influenza virus vaccine is distinct from a monovalent influenza vaccine. The trivalent vaccine targets three influenza strains, while the monovalent vaccine targets a single strain. Clinical trials have evaluated both formulations separately, with the trivalent vaccine studied for seasonal influenza and the monovalent vaccine for pandemic influenza.