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Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative · 1 trial · 1 indication
Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
| Arm | Type | Description |
|---|---|---|
| Group 1: Investigational Quadrivalent Influenza Vaccine | EXPERIMENTAL | Participants will receive a dose of Investigational Quadrivalent Inactivated Influenza Vaccine |
| Group 2: Investigational Trivalent Influenza Vaccine | EXPERIMENTAL | Participants will receive a dose of Investigational Trivalent Inactivated Influenza Vaccine |
| Group 3: Licensed 2010-2011 Trivalent Influenza Vaccine | ACTIVE_COMPARATOR | Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine |
| Group 4: Licensed 2010-2011 Trivalent Influenza Vaccine | ACTIVE_COMPARATOR | Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine |
| Name | Type | Description |
|---|---|---|
| Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative | BIOLOGICAL | 0.5 mL, Intramuscular |
| Investigational Trivalent Inactivated Influenza Vaccine, No Preservative | BIOLOGICAL | 0.5 mL, Intramuscular |
| Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion criteria: * Subject is 18 years of age or older on the day of inclusion. * Informed consent form (ICF) 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 contracep...
Top 6 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 1 | PHASE3 | mRNA-1018-H5 |
| 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 |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Flu/COVID-19 mRNA combination vaccine |
It is an investigational quadrivalent inactivated influenza vaccine formulated without preservative, developed by Sanofi. It is designed to protect against influenza and was studied in a Phase 3 clinical trial among adults. It is a vaccine candidate rather than a marketed product.
It is used for the prevention of influenza. The vaccine targets influenza infection in adults, and the clinical program enrolled healthy volunteers aged 18 years and older. Its intended use is immunization against influenza, the indication studied in its Phase 3 trial.
Sanofi is the developer of the Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative. Sanofi trades under the ticker SNY. The company sponsored the Phase 3 study of this quadrivalent inactivated influenza vaccine candidate.
It is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine is investigational and is not described as approved. The completed study was a randomized, double-blind, active-controlled trial.
The vaccine was studied in NCT01218646, titled Study of Quadrivalent Influenza Vaccine Among Adults. This completed Phase 3 trial enrolled 739 participants in the United States, included both sexes, required participants to be at least 18 years old, and used healthy volunteers in a randomized, double-blind, active-controlled design.