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High-dose quadrivalent influenza virus vaccine · 1 trial · 1 indication
Solicited injection site: Pain, Redness, Swelling, Induration, and Ecchymosis. Solicited systemic reaction: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Unsolicited adverse events, including serious adverse events, will also be collected
| Arm | Type | Description |
|---|---|---|
| QIV HD1 Group | EXPERIMENTAL | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 1) |
| QIV HD2 Group | EXPERIMENTAL | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 2) |
| TIV HD1 Group | ACTIVE_COMPARATOR | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of licensed High Dose trivalent influenza vaccine |
| TIV HD2 Group | ACTIVE_COMPARATOR | Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of investigational High-Dose trivalent influenza vaccine |
| Name | Type | Description |
|---|---|---|
| High-dose quadrivalent influenza virus vaccine | BIOLOGICAL | 0.5 mL, Intramuscular (IM), injected into the deltoid area |
| High-dose influenza virus vaccine | BIOLOGICAL | 0.5 mL, Intramuscular (IM), injected into the deltoid area |
| High-dose trivalent inactivated influenza vaccine | BIOLOGICAL | 0.5 mL, Intramuscular (IM), injected into the deltoid area |
Inclusion Criteria: * Aged ≥ 65 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. Exclusion Criteria: * Participation at the time of trial enrollment (or in the 4 weeks preceding the trial...
High-dose quadrivalent influenza virus vaccine is an investigational vaccine being studied for the prevention of influenza in adults aged 65 years and older. It is designed to provide protection against four influenza virus strains. The vaccine is currently in Phase 2 clinical development and is not yet approved for use.
High-dose quadrivalent influenza virus vaccine is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine for influenza prevention.
High-dose quadrivalent influenza virus vaccine is currently in Phase 2 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to assess its safety and immunogenicity in older adults.
High-dose quadrivalent influenza virus vaccine has been studied in one completed clinical trial, NCT02553343. This Phase 2 study evaluated the safety and immunogenicity of the vaccine in 792 subjects aged 65 years and older in the United States. The trial was randomized, double-blind, and active-controlled.
High-dose quadrivalent influenza virus vaccine is a vaccine designed to stimulate the immune system to produce antibodies against four different influenza virus strains. By presenting these viral components, it aims to generate a protective immune response that can help prevent influenza infection in vaccinated individuals.