Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
QIV-HD · 1 trial · 1 indication
GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (\<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (\>=) 40 (1/dilution) at Day 28, or HAI titer \>=10 (1/dilution) at Day 0 and a \>=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
| Arm | Type | Description |
|---|---|---|
| QIV-HD | EXPERIMENTAL | Participants randomized to receive a single injection of 0.7 mL QIV-HD by intramuscular (IM) route at Day 0. |
| TIV-HD1 (Licensed TIV-HD1) | ACTIVE_COMPARATOR | Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0. |
| TIV-HD2 (Investigational TIV-HD2) | ACTIVE_COMPARATOR | Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. |
| Name | Type | Description |
|---|---|---|
| QIV-HD | BIOLOGICAL | 0.7 mL-dose was administered intramuscularly (IM) into the upper arm area. |
| Licensed TIV-HD1 | BIOLOGICAL | 0.5 mL-dose was administered IM into the upper arm area. |
| Investigational TIV-HD2 | BIOLOGICAL | 0.5 mL-dose was administered IM into the upper arm area. |
Inclusion Criteria: * Aged \>= 65 years on the day of inclusion. * Informed consent form had 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 t...
QIV-HD is a high-dose quadrivalent influenza vaccine being developed by Sanofi for the prevention of influenza in adults aged 65 years and older. It is designed to provide enhanced immune response compared to standard-dose vaccines in this older population, who are at higher risk of influenza-related complications.
QIV-HD is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is responsible for the clinical development and manufacturing of this high-dose quadrivalent influenza vaccine candidate.
QIV-HD is in Phase 3 clinical development. A Phase 3 trial has been completed to evaluate its safety and immunogenicity in participants aged 65 years and older in the United States. It remains an investigational vaccine and is not yet approved for commercial use.
QIV-HD has one completed Phase 3 clinical trial registered under NCT03282240. This randomized, double-blind, active-controlled study enrolled 2,670 healthy volunteers aged 65 years and older in the United States to assess the safety and immunogenicity of the high-dose quadrivalent influenza vaccine.
QIV-HD is a high-dose quadrivalent influenza vaccine that contains four influenza virus strains, including two A strains and two B strains. The higher antigen dose is intended to elicit a stronger immune response in older adults, whose immune systems typically respond less robustly to standard-dose influenza vaccines.