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Influenza virus vaccine · 2 trials · 2 indications
To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV\_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV\_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
| Arm | Type | Description |
|---|---|---|
| Influenza virus vaccine | EXPERIMENTAL | - |
| Comparator influenza vaccine | ACTIVE_COMPARATOR | - |
| cTIV | EXPERIMENTAL | Received one dose of cell-culture derived trivalent influenza vaccine (cTIV). |
| TIV | ACTIVE_COMPARATOR | Received one dose of egg-derived trivalent vaccine (TIV). |
| Name | Type | Description |
|---|---|---|
| Influenza virus vaccine | BIOLOGICAL | Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age. |
| Comparator influenza vaccine | BIOLOGICAL | Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age. |
Inclusion Criteria: * Healthy subjects 3 to 64 years of age Exclusion Criteria: * Receipt of other investigational products within 3 months or other vacine within 1 month; * Allergy to eggs, egg products, or any other vaccine component; * Laboratory confirmed influenza disease within 6 months; * ...
Influenza Virus Vaccine is used for the prevention of influenza disease, commonly known as the flu. It is being developed as a vaccine to protect against seasonal influenza infection.
Influenza Virus Vaccine is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS.
Influenza Virus Vaccine is in Phase 2 clinical development. It has completed one Phase 2 trial and one Phase 3 trial, but it is still an investigational vaccine and has not been approved by regulatory authorities.
Influenza Virus Vaccine has been studied in two completed clinical trials. The first, NCT00264576, was a Phase 2 study in healthy adults in the United States. The second, NCT00464672, was a Phase 3 study in healthy subjects aged 3 to 64 years in Argentina.
Influenza Virus Vaccine is a vaccine designed to protect against influenza, similar in purpose to a standard flu shot. However, it is an investigational product being developed by Novartis and is not yet approved for public use.