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Also known as Licensed TIV-HD1
High-Dose trivalent influenza vaccine · 1 trial · 1 indication
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage.
Anti-influenza antibodies will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Seroconversion status 28 days after vaccination (ie, preinjection Ab titer \< 10 \[1/dil\] at Day 1 and post-injection Ab titer≥ 40 \[1/dil\] at Day 29 or preinjection Ab titer ≥ 10 \[1/dil\] at Day 1 and a ≥ 4-fold increase in titer \[1/dil\] at Day 29).
| Arm | Type | Description |
|---|---|---|
| IIV-HD | EXPERIMENTAL | Participants will receive a single intramuscular (IM) injection of IIV-HD at Day 1 |
| IIV-SD | ACTIVE_COMPARATOR | Participants will receive a single intramuscular (IM) injection of IIV-SD at Day 1 |
| Name | Type | Description |
|---|---|---|
| High-Dose trivalent influenza vaccine (Split virion, Inactivated) | BIOLOGICAL | Liquid suspension for intramuscular injection |
| Standard-dose trivalent influenza vaccine (Split virion, Inactivated) | BIOLOGICAL | Liquid suspension for intramuscular injection |
Inclusion Criteria: * Aged 50 to 64 years on the day of inclusion. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female m...
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 |
High-Dose trivalent influenza vaccine is an investigational vaccine developed by Sanofi for the prevention of influenza. It is a split virion, inactivated vaccine designed to protect against three influenza virus strains. It is being studied in adults 50 through 64 years of age and has completed a Phase 3 clinical trial.
High-Dose trivalent influenza vaccine is intended for the prevention of influenza in adults. The completed Phase 3 trial enrolled adults 50 through 64 years of age in the United States. The vaccine targets three influenza strains, which is what the trivalent designation refers to.
Sanofi develops High-Dose trivalent influenza vaccine. Sanofi trades on the New York Stock Exchange under the ticker symbol SNY. The company is the sponsor of the Phase 3 trial evaluating the vaccine in adults 50 through 64 years of age.
High-Dose trivalent influenza vaccine has completed a Phase 3 clinical trial. It is an investigational vaccine and is not described as approved. The Phase 3 study, NCT06641180, evaluated immunogenicity and safety in adults 50 through 64 years of age and has a completed status.
High-Dose trivalent influenza vaccine has been studied in one completed Phase 3 trial, NCT06641180, titled Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age. The trial enrolled 1,180 participants in the United States, was randomized, double blind, and active controlled.