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A/H5N1 inactivated, split-virion influenza virus · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Study Group 1 | EXPERIMENTAL | Vaccine with adjuvant |
| Study Group 2 | EXPERIMENTAL | Vaccine without adjuvant |
| Name | Type | Description |
|---|---|---|
| A/H5N1 inactivated, split-virion influenza virus | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 18 to 60 years on day of inclusion. * Informed Consent Form signed. * Able to attend all scheduled visits and to comply with all trial procedures. * For a woman, inability to bear a child or negative urine pregnancy test. * For a woman of child-bearing potential, use of a...
A/H5N1 inactivated, split-virion influenza virus is an investigational vaccine being developed for influenza, specifically targeting the H5N1 avian influenza strain. It is designed to prevent infection caused by the H5N1 virus, which can cause severe respiratory illness. The vaccine is currently in Phase 2 clinical development and is not yet approved for public use.
A/H5N1 inactivated, split-virion influenza virus is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and immunogenicity of this pandemic influenza vaccine candidate in adult populations.
A/H5N1 inactivated, split-virion influenza virus is in Phase 2 clinical development. Two Phase 2 trials have been completed, involving a total of 700 participants. The vaccine is investigational and has not received regulatory approval. It has been granted several FDA designations, including Fast Track, Orphan Drug, Priority Review, and Breakthrough Therapy.
A/H5N1 inactivated, split-virion influenza virus has been studied in two completed Phase 2 trials. NCT00415129 enrolled 600 adults and elderly participants in Belgium and the United Kingdom, while NCT00545701 enrolled 100 adults in Australia. Both trials assessed the safety and immunogenicity of the intramuscular vaccine in healthy volunteers aged 18 years and older.
A/H5N1 inactivated, split-virion influenza virus is not FDA approved. It is an investigational vaccine currently in Phase 2 clinical development. Although it has received FDA designations such as Fast Track, Orphan Drug, Priority Review, and Breakthrough Therapy, these designations do not indicate approval. The vaccine remains under clinical investigation.