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Swine A/H1N1 influenza vaccine · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Swine-origin A/H1N1 Vaccine Low-dose |
| Study Group 2 | EXPERIMENTAL | Swine-origin A/H1N1 Vaccine High-dose |
| A/H1N1 Vaccine Group 1 | EXPERIMENTAL | All participants will receive A/H1N1 Influenza vaccine formulation 1 at Visits 1 and 2; and a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset) |
| A/H1N1 Vaccine Group 2 | EXPERIMENTAL | All participants will receive A/H1N1 Influenza vaccine formulation 2 at Visits 1 and 2; and a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). |
| A/H1N1 Vaccine Group 3 | EXPERIMENTAL | Participants will receive A/H1N1 Influenza vaccine formulation 3 |
| Name | Type | Description |
|---|---|---|
| Swine A/H1N1 influenza vaccine (split virion, inactivated) | BIOLOGICAL | 0.3 mL, Intramuscular (IM) |
| Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset) |
Inclusion Criteria : * Aged 18 to 60 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential, use of an effective method of contraception from at least 4 wee...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
The Swine A/H1N1 influenza vaccine is used to protect against swine-origin A/H1N1 influenza. It is an inactivated, split virion vaccine developed by Sanofi. The vaccine has been studied in healthy adults, the elderly, and children, including infants as young as 6 months, across Phase 2 clinical trials.
Sanofi develops the Swine A/H1N1 influenza vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The vaccine is an inactivated, split virion formulation studied for prevention of swine-origin A/H1N1 influenza in healthy volunteers.
The Swine A/H1N1 influenza vaccine is in Phase 2 clinical development. All four of its recorded trials are Phase 2 studies, and all four are completed. No active trials are currently listed. The vaccine is investigational and has not been established as approved for use.
Four completed Phase 2 trials studied the Swine A/H1N1 influenza vaccine: NCT01089660 in healthy adults in France, NCT00956202 in European subjects aged 3 to 17 years in Finland, NCT00956046 in children aged 6 to 35 months in Finland, and NCT00954798 in adults and the elderly in France. Total enrollment was 1,356 participants.
The Swine A/H1N1 influenza vaccine is an inactivated, split virion vaccine directed against swine-origin A/H1N1 influenza. It is a preventive vaccine candidate developed by Sanofi. Its Phase 2 trials enrolled healthy volunteers, including adults, the elderly, and children, and used controlled, randomized study designs.