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Multi-dose Quadrivalent Influenza Vaccine · 1 trial · 1 indication
Anti-hemagglutinin (HA) antibody titers against the 4 influenza strains are assessed by a hemagglutination inhibition (HAI) assay
Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. GMT ratio is assessed as the individual ratio of post-/pre-vaccination titers
Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. Seroconversion is defined as either post-vaccination titer ≥ 40 (1/dil), or pre-vaccination titer ≥ 10 (1/dil) and ≥ 4-fold increase in post-vaccination titer
| Arm | Type | Description |
|---|---|---|
| Multi-dose Quadrivalent Influenza Vaccine | EXPERIMENTAL | Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal containing) in multi-dose presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart |
| Single-dose Quadrivalent Influenza Vaccine | ACTIVE_COMPARATOR | Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal free) in single-dose syringe presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart |
| Name | Type | Description |
|---|---|---|
| Multi-dose Quadrivalent Influenza Vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
| Single-dose Quadrivalent Influenza Vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
Inclusion Criteria: * Aged 6 months to 17 years on the day of inclusion * Assent form has been signed and dated by the subject aged 7 to 17 years, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if requ...
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 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| 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 |
The Multi-dose Quadrivalent Influenza Vaccine is an investigational vaccine developed by Sanofi for the prevention of influenza. It is designed as a quadrivalent formulation, meaning it covers four influenza virus strains. It is being studied in a Phase 3 clinical program and has been tested in a completed trial in Mexico.
The Multi-dose Quadrivalent Influenza Vaccine is intended for the prevention of influenza. Its Phase 3 trial enrolled healthy volunteers starting at 6 months of age, indicating development for both young children and older populations. The vaccine is not yet approved and remains in clinical development.
Sanofi develops the Multi-dose Quadrivalent Influenza Vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the sponsor of the Phase 3 trial evaluating the vaccine.
The Multi-dose Quadrivalent Influenza Vaccine is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA.
The Multi-dose Quadrivalent Influenza Vaccine has been evaluated in one completed Phase 3 trial, NCT03391193, titled Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine. The trial enrolled 301 participants in Mexico, was randomized and active-controlled, and included healthy volunteers aged 6 months and older.