A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine

Phase 4 Completed 450 enrolled Sinovac (Dalian) Vaccine Technology Co., Ltd.

RandomizedParallel-groupOpen-labelPrevention

Summary

This study is a randomized and controlled Phase IV clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of combined immunization with live attenuated varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months.

Timeline

Start: 2021-04-08
Primary completion: 2021-04-08
Completion: 2022-02-27

Outcome

Met primary endpoint

paper anti-VZV antibodies and anti-HAV antibodies were -5.86% and -2.90%, which greater than the predefined non-inferiority margin (-10%). PMID 36593652 ↗

Publications

Sun D, Yu D, Du Z, Jia N, Liu X, Sun J, Xu Q, Sun Z, Luan C, Lv J, Xiong P, Zhang L, Sha X, Gao Y, Kang D. Immunogenicity and safety of a live attenuated varicella vaccine co-administered with inactive hepatitis A vaccine: A phase 4, single-center, randomized, controlled trial. Hum Vaccin Immunother. 2023 Dec 31;19(1):2161789. doi: 10.1080/21645515.2022.2161789. Epub 2023 Jan 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inactivated hepatitis A vaccine	Vaccine	0.5 ml	—
Subject	Inactivated hepatitis A vaccine	Vaccine	250 iu	—
Subject	Live Attenuated Varicella Vaccine	Vaccine	0.5 ml	—