Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Control Quadrivalent influenza virus vaccine · 1 trial · 1 indication
Seroconversion rates of HI antibody at day 28 after the last dose for each of the four antigens.
GMTs of HI antibody at day 28 after the last dose for each of the four antigens.
| Arm | Type | Description |
|---|---|---|
| Sinovac-QIV group | EXPERIMENTAL | 800 subjects aged 3 years and older will receive one dose of Sinovac-QIV for vaccine-primed subjects or two doses of Sinovac-QIV for vaccine-unprimed subjects. |
| Vaxigrip Tetra-QIV group | ACTIVE_COMPARATOR | 800 subjects aged 3 years and older will receive one dose of Vaxigrip Tetra-QIV for vaccine-primed subjects or two doses of Vaxigrip Tetra-QIV for vaccine-unprimed subjects. |
| Name | Type | Description |
|---|---|---|
| Influenza Vaccine (Split Virion), Inactivated, Quadrivalent | BIOLOGICAL | The influenza vaccines (Split Virion), inactivated, quadrivalent are developed by Sinovac Biotech Co., Ltd.15 μg hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride,disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region. |
| Control Quadrivalent influenza virus vaccine | BIOLOGICAL | The Control Quadrivalent influenza virus vaccines are manufactured by Sanofi and are purchased by Pontifical Catholic University of Chile.15μg HA of each of the four influenza strains in 0.5 mL of solution per injection.The routine of administration is intramuscular injection into deltoid region. |
Inclusion Criteria: * Volunteers age 3 years and older, in good health or medically stable; * Written informed consent obtained from subjects or/and legal guardian; * No receipt of influenza vaccines within 6 months or plans to receive any influenza vaccines during the study; * Female subjects of n...
Control Quadrivalent influenza virus vaccine is an investigational quadrivalent influenza vaccine being developed for the prevention of seasonal influenza. It is designed to provide protection against four influenza virus strains. The vaccine is currently in Phase 3 clinical development and is not yet approved for use.
Control Quadrivalent influenza virus vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company's stock is traded under the ticker symbol SVA. Sinovac is conducting clinical trials to evaluate the vaccine's immunogenicity and safety for seasonal influenza prevention.
Control Quadrivalent influenza virus vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 3 clinical trial has been completed to assess its immunogenicity and safety in preventing seasonal influenza.
Control Quadrivalent influenza virus vaccine has one completed Phase 3 clinical trial, identified as NCT05431725. This study evaluated the immunogenicity and safety of the quadrivalent influenza vaccine in 2,202 participants aged 3 years and older in Chile and the Philippines. The trial was randomized, double-blind, and active-controlled.
Control Quadrivalent influenza virus vaccine is a quadrivalent influenza vaccine designed to stimulate the immune system to produce antibodies against four influenza virus strains. By presenting inactivated split virion antigens, it primes the body to recognize and fight seasonal influenza viruses, potentially reducing the risk of infection.