

@article {1950,
	title = {Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China},
	journal = {The New England Journal of Medicine},
	volume = {370},
	number = {9},
	year = {2014},
	note = {Zhu, Fengcai Xu, Wenbo Xia, Jielai Liang, Zhenglun Liu, Yan Zhang, Xuefeng Tan, Xiaojuan Wang, Ling Mao, Qunying Wu, Junyu Hu, Yuemei Ji, Tianjiao Song, Lifei Liang, Qi Zhang, Baomin Gao, Qiang Li, Jingxin Wang, Shenyu Hu, Yuansheng Gu, Shanru Zhang, Jianhua Yao, Genhong Gu, Jianxiang Wang, Xushan Zhou, Yuchun Chen, Changbiao Zhang, Minglei Cao, Minquan Wang, Junzhi Wang, Hua Wang, Nan eng Clinical Trial, Phase III Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov{\textquoteright}t 2014/02/28 06:00 N Engl J Med. 2014 Feb 27;370(9):818-28. doi: 10.1056/NEJMoa1304923.},
	pages = {818-28},
	type = {Journal Article},
	abstract = {<p>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. The surveillance period was 12 months. The primary end point was the occurrence of EV71-associated hand, foot, and mouth disease or herpangina. RESULTS: During the 12-month surveillance period, EV71-associated disease was identified in 0.3\% of vaccine recipients (13 of 5041 children) and 2.1\% of placebo recipients (106 of 5028 children) in the intention-to-treat cohort. 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\&lt;0.001) in this cohort. Vaccine efficacies against EV71-associated hospitalization (0 cases vs. 24 cases) and hand, foot, and mouth disease with neurologic complications (0 cases vs. 8 cases) were both 100\% (95\% CI, 83.7 to 100 and 42.6 to 100, respectively). Serious adverse events occurred in 111 of 5044 children in the vaccine group (2.2\%) and 131 of 5033 children in the placebo group (2.6\%). In the immunogenicity subgroup (1291 children), an anti-EV71 immune response was elicited by the two-dose vaccine series in 98.8\% of participants at day 56. An anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71-associated hand, foot, and mouth disease or herpangina. CONCLUSIONS: The EV71 vaccine provided protection against EV71-associated hand, foot, and mouth disease or herpangina in infants and young children. (Funded by Sinovac Biotech; ClinicalTrials.gov number, NCT01507857.).</p>
},
	keywords = {Antibodies, Foot and Mouth Disease/immunology/*prevention \& control Herpangina/*prevention \& control Humans Infant Injections, Human/genetics/*immunology Female Hand, Inactivated Viral Vaccines/administration \& dosage/adverse effects/*immunology, Intramuscular Male Vaccines, Neutralizing/blood Antibodies, Preschool China Double-Blind Method Enterovirus A, Viral/blood Child},
	issn = {1533-4406 (Electronic) 0028-4793 (Linking)},
	doi = {10.1056/NEJMoa1304923},
	url = {http://www.ncbi.nlm.nih.gov/pubmed/24571754},
	author = {Zhu, F. and Xu, W. and Xia, J. and Liang, Z. and Liu, Y. and Zhang, X. and Tan, X. and Wang, L. and Mao, Q. and Wu, J. and Hu, Y. and Ji, T. and Song, L. and Liang, Q. and Zhang, B. and Gao, Q. and Li, J. and Wang, S. and Hu, Y. and Gu, S. and Zhang, J. and Yao, G. and Gu, J. and Wang, X. and Zhou, Y. and Chen, C. and Zhang, M. and Cao, M. and Wang, J. and Wang, H. and Wang, N.}
}
