Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trivalent split influenza vaccine · 2 trials · 3 indications
The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to \<36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.
| Arm | Type | Description |
|---|---|---|
| aTIV (6 to <72 months) | ACTIVE_COMPARATOR | Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29 |
| Comparator TIV (6 to <72 months) | ACTIVE_COMPARATOR | Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29 |
| TIV (6 to <72 months) | ACTIVE_COMPARATOR | Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29 |
| Name | Type | Description |
|---|---|---|
| Trivalent split influenza vaccine (TIV) | BIOLOGICAL | - |
| MF59-adjuvanted trivalent influenza vaccine (aTIV) | BIOLOGICAL | - |
| Licensed comparator trivalent split influenza vaccine (comparator TIV) | BIOLOGICAL | - |
| trivalent split influenza vaccine | BIOLOGICAL | - |
Inclusion Criteria: 1.Children 6 months to 72 months of age. Exclusion Criteria:Children 1. Who had been hospitalized at the time of enrollment 2. Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein 3. Who had known impairment of the immune function...
Trivalent split influenza vaccine is used for the prevention of seasonal influenza and influenza disease. It is an investigational vaccine being developed for immunization against seasonal flu strains. The vaccine is designed to elicit an immune response against three influenza virus strains included in the seasonal composition.
Trivalent split influenza vaccine is being developed by Novartis AG, which trades under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and immunogenicity of the vaccine in different populations, including adults and children.
Trivalent split influenza vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 trials are completed and were designed to assess safety and immunogenicity in healthy volunteers.
Trivalent split influenza vaccine has been studied in two completed Phase 3 trials. NCT00498303 evaluated safety and immunogenicity in 120 adults in Germany using the 2007/2008 strain composition. NCT01346592 compared it to adjuvanted and non-adjuvanted subunit vaccines in 6,104 children aged 6 to 72 months across multiple countries.
No, Trivalent split influenza vaccine is not the same as adjuvanted trivalent subunit influenza vaccine. They are different vaccine formulations. A clinical trial compared the adjuvanted trivalent subunit vaccine and the non-adjuvanted trivalent subunit vaccine against the non-adjuvanted trivalent split influenza vaccine in children.