A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months

Phase 3 Completed 3300 enrolled Sinovac Biotech Co., Ltd

RandomizedParallel-groupQuadruple-blindPrevention

Summary

A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the Immunogenicity and safety of the vaccine.

Timeline

Start: 2023-09-16
Primary completion: 2024-05-23
Completion: 2024-05-23

Outcome

Met primary endpoint

paper The full-dose and half-dose QIVs demonstrated non-inferiority to the half-dose TIVs in terms of SCRs and GMTs for all shared strains. PMID 41391373 ↗

paper The immunogenicity of both the full-dose and half-dose QIVs were non-inferior to the licensed half-dose TIVs. PMID 41391373 ↗

Publications

Wang L, Li L, Yang W, Pang X, Li D, Zhu T, Wang S, Li T, Tian Y, Jiang Z, Li J, Yang X, Zhao C, Tang J, Tong Y. Immunogenicity and safety of inactivated quadrivalent influenza vaccines in children aged 6-35 months: A multi-center, randomized, double-blind, active-controlled clinical trial. Vaccine. 2026 Jan 25;71:128113. doi: 10.1016/j.vaccine.2025.128113. Epub 2025 Dec 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quadrivalent influenza vaccine	Vaccine	7.5 ug	Intramuscular
Subject	Quadrivalent influenza vaccine	Vaccine	15 ug	Intramuscular
Subject	Quadrivalent influenza vaccine	Vaccine	0.25 ml	Intramuscular
Subject	Quadrivalent influenza vaccine	Vaccine	0.5 ml	Intramuscular
Comparator	Trivalent influenza vaccine(BV)	Vaccine	7.5 ug	Intramuscular
Comparator	Trivalent influenza vaccine(BV)	Vaccine	0.25 ml	Intramuscular
Comparator	Trivalent influenza vaccine(BY)	Vaccine	7.5 ug	Intramuscular
Comparator	Trivalent influenza vaccine(BY)	Vaccine	0.25 ml	Intramuscular