Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)

Summary

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.

Timeline

Start

2018-02-06

Primary completion

2018-04-17

Completion

2018-11-02

Outcome

Mixed primary results

paper The primary objective was to evaluate the non-inferiority immunogenicity of QIV compared with the two TIVs PMID 32347785 ↗

paper QIV was found non-inferior to TIVs for shared strains (A/H1N1 and A/H3N2) PMID 32347785 ↗

paper The BV strain in QIV did not reach the non-inferiority criteria PMID 32347785 ↗

Publications

• Hu Y, Shao M, Hu Y, Liang Q, Jia N, Chu K, Xu L, Li J, Li C, Zhu F. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: a randomized, double-blind, controlled phase III clinical trial in children aged 6-35 months in China. Hum Vaccin Immunother. 2020 Jul 2;16(7):1691-1698. doi: 10.1080/21645515.2020.1721994. Epub 2020 Apr 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quadrivalent influenza vaccine	Vaccine	7.5 ug	—
Subject	Quadrivalent influenza vaccine	Vaccine	0.25 ml	—
Comparator	trivalent influenza vaccine (contains B/Victoria strain)	Vaccine	7.5 ug	—
Comparator	trivalent influenza vaccine (contains B/Victoria strain)	Vaccine	0.25 ml	—
Comparator	trivalent influenza vaccine (contains B/Yamagata strain)	Vaccine	7.5 ug	—
Comparator	trivalent influenza vaccine (contains B/Yamagata strain)	Vaccine	0.25 ml	—

Indications