drugset / Trial / NCT05431725

Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

NCT05431725 ↗

Phase 3 Completed 2202 enrolled Sinovac Biotech Co., Ltd
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to evaluate the safety and immunogenicity of Influenza vaccine (Split virion), Inactivated, Quadrivalent developed by Sinovac Biotech Co., Ltd. (Sinovac-QIV) as compared to a licensed comparator in Chile and Philippines, Vaxigrip Tetra™ (Vaxigrip Tetra-QIV) in individuals aged 3 years and older.

Timeline

Start
2022-07-18
Primary completion
2023-07-19
Completion
2023-07-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator Control Quadrivalent influenza virus vaccine Vaccine 15 ug Intramuscular
Comparator Control Quadrivalent influenza virus vaccine Vaccine 0.5 ml Intramuscular
Subject Influenza Vaccine (Split Virion), Inactivated, Quadrivalent Vaccine 15 ug Intramuscular
Subject Influenza Vaccine (Split Virion), Inactivated, Quadrivalent Vaccine 0.5 ml Intramuscular

Indications