An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

Timeline

Start

2012-01

Primary completion

2013-03

Completion

2013-03

Outcome

Met primary endpoint

paper The vaccine efficacy against EV71-associated hand, foot, and mouth disease or herpangina was 94.8% (95% confidence interval [CI], 87.2 to 97.9; P<0.001) in this cohort. PMID 24571754 ↗

release “该疫苗在目标人群中针对 EV71 相关的手足口病或疱疹性咽峡炎的保护率达到 94.8%” sinovac.com ↗

Publications

• Zhu F, Xu W, Xia J, Liang Z, Liu Y, Zhang X, Tan X, Wang L, Mao Q, Wu J, Hu Y, Ji T, Song L, Liang Q, Zhang B, Gao Q, Li J, Wang S, Hu Y, Gu S, Zhang J, Yao G, Gu J, Wang X, Zhou Y, Chen C, Zhang M, Cao M, Wang J, Wang H, Wang N. Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China. N Engl J Med. 2014 Feb 27;370(9):818-28. doi: 10.1056/NEJMoa1304923.
• Chong P, Hsieh SY, Liu CC, Chou AH, Chang JY, Wu SC, Liu SJ, Chow YH, Su IJ, Klein M. Production of EV71 vaccine candidates. Hum Vaccin Immunother. 2012 Dec 1;8(12):1775-83. doi: 10.4161/hv.21739. Epub 2012 Sep 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EV71 vaccine	Vaccine	0.5 ml	Intramuscular
Subject	EV71 vaccine	Vaccine	400 iu	Intramuscular

Indications