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Standard-Dose influenza virus surface antigens, Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere 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, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.
| Arm | Type | Description |
|---|---|---|
| Group 1: QIV-HD | EXPERIMENTAL | Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0. |
| Group 2: QIV-SD | ACTIVE_COMPARATOR | Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. |
| Name | Type | Description |
|---|---|---|
| Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD) | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
| High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
Inclusion criteria : * Sixty years of age and older on the day of inclusion. * Able to attend all scheduled visits and complied with all trial procedures. Exclusion criteria: * Participant was pregnant, or lactating, or of childbearing potential and did not used an effective method of contracepti...
It is an inactivated quadrivalent influenza vaccine containing surface antigens (haemagglutinin and neuraminidase) from the 2019-2020 Northern Hemisphere influenza strains. It is designed for influenza immunization and is given as a standard dose. Sanofi developed it, and it was studied in adults 60 years of age and older.
It is used for influenza immunization, specifically to protect against the influenza strains selected for the 2019-2020 Northern Hemisphere season. The clinical study enrolled healthy volunteers aged 60 years and older in six European countries, a population at higher risk of influenza complications.
Sanofi develops this quadrivalent influenza vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The vaccine was evaluated in a Phase 3 study comparing it with a high-dose quadrivalent influenza vaccine in older adults.
It has been studied in Phase 3 clinical development. The single registered trial, NCT04024228, is completed, and no trials for this specific 2019-2020 Northern Hemisphere formulation are currently active. It is an investigational product evaluated in clinical research rather than a newly approved vaccine.
It was evaluated in the Phase 3 trial NCT04024228, titled a study to assess the immune response and safety profile of a high-dose quadrivalent influenza vaccine compared to a standard-dose quadrivalent influenza vaccine in European adults 60 years of age and older. The trial was randomized, double-blind, active-controlled, and enrolled 1,539 participants across Belgium, France, Germany, Italy, Netherlands, and Poland.
Yes. QIV-SD is the abbreviated name for Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains. QIV-SD stands for quadrivalent influenza vaccine, standard dose, and refers to the same inactivated vaccine product.