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Also known as Fluzone® High-Dose
High-Dose Trivalent Inactivated Influenza Vaccine · 1 trial · 1 indication
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Seroconversion: For participants with a Day 0 (pre-vaccination) titer \< 10 (1/dilution \[1/dil\]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28. Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
Seroprotection was defined as a titer ≥ 40 (1/dilution \[1/dil\]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
| Arm | Type | Description |
|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | EXPERIMENTAL | - |
| Trivalent Inactivated Influenza Vaccine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | BIOLOGICAL | 0.5 mL Intramuscular |
| Trivalent Inactivated Influenza Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 50 to 64 years (inclusive) on the day of vaccination * Informed consent form has been signed and dated * Medically stable * 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 c...
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 |
High-Dose Trivalent Inactivated Influenza Vaccine is an investigational vaccine developed by Sanofi for the prevention of influenza. It is designed to provide protection against three influenza virus strains and is being studied in adults 50 to 64 years of age. It remains in clinical development and is not approved for use.
High-Dose Trivalent Inactivated Influenza Vaccine is being developed for the prevention of influenza. The clinical program has focused on adults 50 to 64 years of age, a group at increased risk of influenza-related complications. It is an investigational product and has not been approved for any indication.
High-Dose Trivalent Inactivated Influenza Vaccine is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating this vaccine candidate.
High-Dose Trivalent Inactivated Influenza Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory agency. Further studies would be required to establish its safety and efficacy.
High-Dose Trivalent Inactivated Influenza Vaccine has been evaluated in one completed Phase 2 trial, NCT01258595, titled A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age. The trial enrolled 300 participants in the United States and was randomized, double-blind, and active-controlled.