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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...
High-Dose Trivalent Inactivated Influenza Vaccine is an investigational vaccine being studied for the prevention of influenza in adults. It is designed to provide protection against seasonal flu strains. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
High-Dose Trivalent Inactivated Influenza Vaccine is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and effectiveness in preventing influenza.
High-Dose Trivalent Inactivated Influenza Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 2 trial has been completed, and the vaccine is being evaluated for its ability to protect against influenza in adults.
High-Dose Trivalent Inactivated Influenza Vaccine has been studied in a Phase 2 clinical trial with the identifier NCT01258595. This completed trial enrolled 300 participants in the United States and evaluated the vaccine in healthy adults aged 50 to 64 years. The trial was randomized, double-blind, and active-controlled.
High-Dose Trivalent Inactivated Influenza Vaccine is a high-dose formulation of a trivalent inactivated influenza vaccine. It is designed to elicit a stronger immune response compared to standard-dose vaccines. The vaccine is being studied specifically in adults 50 to 64 years of age to assess its safety and immunogenicity.