Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Seasonal flu vaccine · 2 trials · 1 indication
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).
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | 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 flu vaccine | BIOLOGICAL | This phase II is performed as a multicenters study site in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22) |
Key Inclusion Criteria: * Males and females volunteers of 65 years of age or older * Mentally competent * Willing and able to give written informed consent prior to study entry. * Able to comply with all the study requirements. * In general good health Key Exclusion Criteria: * Any serious chroni...
The Novartis seasonal flu vaccine is an investigational vaccine developed by Novartis AG for the prevention of seasonal influenza. It is a vaccine modality that has been studied in Phase 2 clinical trials. The program includes two completed trials that evaluated different formulations in elderly and pediatric populations.
The seasonal flu vaccine is intended for the prevention of seasonal influenza, an infectious disease. It has been tested in Phase 2 trials involving healthy volunteers, including elderly subjects and children as young as one year old. The vaccine aims to protect against influenza virus infection.
The seasonal flu vaccine is being developed by Novartis AG, a pharmaceutical company traded under the ticker NVS. Novartis conducted the clinical trials for this vaccine candidate.
The seasonal flu vaccine is in Phase 2 of clinical development. Two Phase 2 trials have been completed, and there are currently no active trials. It is an investigational vaccine and has not been approved by the FDA for seasonal influenza prevention.
The seasonal flu vaccine has been evaluated in two completed Phase 2 trials: NCT01152814, which studied a sub-unit adjuvanted influenza vaccine in elderly subjects in Italy, and NCT01123954, which assessed trivalent subunit inactivated influenza vaccines in Vietnamese volunteers. Both trials are completed and enrolled a total of 97 participants.