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Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains · 1 trial · 2 indications
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28.
| Arm | Type | Description |
|---|---|---|
| Group 1: QIV-HD | EXPERIMENTAL | Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. |
| Group 2: QIV-SD | ACTIVE_COMPARATOR | Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0. |
| Name | Type | Description |
|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD) | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
| Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD) | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: SC |
Inclusion criteria : * Aged greater than or equal to (\>=) 60 years on the day of inclusion. * Able to attend all scheduled visits and complied with all study procedures. Exclusion criteria: * Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or pla...
It is a quadrivalent influenza vaccine used for influenza immunization. The 2020-2021 strains formulation is designed to protect against four influenza virus strains in a single season. It is given as a standard dose and is intended for active immunization against influenza.
Sanofi develops this vaccine, and the company trades under the ticker SNY. Sanofi is the developer listed for the asset.
It is in Phase 3 development. The vaccine is investigational and has been studied in a completed Phase 3 trial. It is not described as approved.
It was evaluated in NCT04498832, a Phase 3 study comparing a high-dose quadrivalent influenza vaccine with this standard-dose quadrivalent influenza vaccine in Japanese adults 60 years of age and older. The trial enrolled 2,100 participants, was randomized, double-blind, and active-controlled, and is completed.
Yes. QIV-SD is an alternative name for Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains. QIV-SD stands for quadrivalent influenza vaccine, standard dose.