Fengcai Zhu, Wenbo Xu, Jielai Xia, Zhenglun Liang, Yan Liu, Xuefeng Zhang, Xiaojuan Tan, Ling Wang, Qunying Mao, Junyu Wu, Yuemei Hu, Tianjiao Ji, Lifei Song, Qi Liang, Baomin Zhang, Qiang Gao, Jingxin Li, Shenyu Wang, Yuansheng Hu, Shanru Gu, Jianhua Zhang, Genhong Yao, Jianxiang Gu, Xushan Wang, Yuchun Zhou, Changbiao Chen, Minglei Zhang, Minquan Cao, Junzhi Wang, Hua Wang, Nan Wang
BACKGROUND: Enterovirus 71 (EV71) is one of the major causative agents of outbreaks of hand, foot, and mouth disease or herpangina worldwide. This phase 3 trial was designed to evaluate the efficacy, safety, and immunogenicity of an EV71 vaccine. METHODS: We conducted a randomized, double-blind, placebo-controlled, multicenter trial in which 10,007 healthy infants and young children (6 to 35 months of age) were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either EV71 vaccine or placebo, 28 days apart...
February 27, 2014: New England Journal of Medicine