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Split, Inactivated, Trivalent Influenza Vaccine · 2 trials · 3 indications
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Split, Inactivated, Trivalent Influenza Vaccine |
| 2 | EXPERIMENTAL | Split, Inactivated, Trivalent Influenza Vaccine |
| 3 | ACTIVE_COMPARATOR | Split, Inactivated, Trivalent Influenza Vaccine |
| 4 | ACTIVE_COMPARATOR | Split, Inactivated, Trivalent Influenza Vaccine |
| Fluzone Intradermal (ID) Vaccine Group | EXPERIMENTAL | Participants received a dose of Fluzone Intradermal (ID) Influenza Vaccine |
| Fluzone Intramuscular (IM) Vaccine Group | ACTIVE_COMPARATOR | Participants received a dose of Fluzone Intramuscular (IM) Influenza Vaccine. |
| Name | Type | Description |
|---|---|---|
| Split, Inactivated, Trivalent Influenza Vaccine | BIOLOGICAL | Vaccine (infant dose) |
| Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) | BIOLOGICAL | Vaccine (infant dose) |
Inclusion Criteria : * Aged 6 months to 8 years but not yet 9 years on the day of inclusion. * Subject is healthy, as determined by medical history. * Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved in...
Split, Inactivated, Trivalent Influenza Vaccine is an investigational vaccine being studied for the prevention of Orthomyxoviridae infection, which includes influenza and myxovirus infection. It is developed by Sanofi (SNY) and is currently in Phase 2 clinical development. The vaccine is intended for use in elderly subjects aged 65 years and older, as well as infants and children aged 6 months and older.
Split, Inactivated, Trivalent Influenza Vaccine is developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in different age groups, including elderly subjects and pediatric populations.
Split, Inactivated, Trivalent Influenza Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, involving a total of 1,337 participants, to assess the vaccine compared with a standard Fluzone vaccine.
Split, Inactivated, Trivalent Influenza Vaccine has been studied in two completed Phase 2 clinical trials. NCT00388583 enrolled 817 elderly subjects aged 65 years and older in the United States. NCT00391391 enrolled 520 infants and children aged 6 months and older in the United States. Both trials compared the vaccine with standard Fluzone vaccine.
Split, Inactivated, Trivalent Influenza Vaccine is not the same as Fluzone. It is an investigational vaccine being compared with Fluzone, which is a standard licensed influenza vaccine, in clinical trials. The studies were designed to evaluate how the investigational vaccine performs relative to Fluzone in different age groups.