drugset

drugset / Trial / NCT03873740

Immunogenicity and Safety of Two Different Commercial EV71 Vaccines

NCT03873740 ↗

Phase 4 Completed 300 enrolled Sinovac Biotech Co., Ltd Shandong Province Centers for Disease Control and Prevention · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.

Timeline

Start: 2018-11-06
Primary completion: 2019-01-21
Completion: 2019-01-23

Publications

Xu Q, Cao Q, Yang W, Liu X, Liu H, Tian X, Li J, Fang X, Jia N, Zeng G, Xu A. Interchangeability of two Enterovirus 71 inactivated vaccines in Chinese children: A phase IV, open-label, and randomized controlled trial. Vaccine. 2020 Mar 10;38(12):2671-2677. doi: 10.1016/j.vaccine.2020.02.013. Epub 2020 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EV71 inactived vaccine（Human diploid cells）	Vaccine	—	—
Subject	EV71 inactived vaccine（Vero cells）	Vaccine	—	—

Indications