Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated

Phase 4 Completed 1260 enrolled Sinovac Biotech Co., Ltd

RandomizedParallel-groupSingle-blindPrevention

Summary

This study is a randomized, double-blind phase Ⅳ clinical trial of quadrivalent influenza vaccine (Split Virion), inactivated manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated in health subjects aged 9-59 years old.

Timeline

Start: 2022-11-27
Primary completion: 2023-01-24
Completion: 2023-01-24

Outcome

Met primary endpoint

paper the 95% confidence intervals (CIs) of GMT ratios for all 4 strains falling into the equivalence criterion of (0.67, 1.5). PMID 39116486 ↗

Publications

Gao Y, Yang X, Li X, Chen H, Li Y, Tan X, Yu D, Feng T, Zhou S, Lei S, Zhao C, Wang J, Guan Q. Lot-to-lot consistency, immunogenicity and safety of a quadrivalent split virion inactivated influenza vaccine in healthy population aged 9-59 years: A randomized, double-blind, controlled, phase IV clinical trial. Vaccine. 2024 Aug 30;42(21):126182. doi: 10.1016/j.vaccine.2024.126182. Epub 2024 Aug 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quadrivalent influenza vaccine(Split Virion),Inactivated	Vaccine	15 ug	Intramuscular
Subject	Quadrivalent influenza vaccine(Split Virion),Inactivated	Vaccine	0.5 ml	Intramuscular