Rotavirus vaccine RIX4414 efficacy sustained during the third year of life: A randomized clinical trial in an Asian population

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• 作者：Kong Boo Phua^a ; ^{Phua.Kong.Boo@kkh.com.sg} ; Fong Seng Lim^b ; ^{fong_seng_lim@nhgp.com.sg} ; Yu Lung Lau^c ; ^{lauylung@hkucc.hku.hk} ; Edmund Anthony Severn Nelson^d ; ^{tony-nelson@cuhk.edu.hk} ; Li Min Huang^e ; ^{lmhuang@ntu.edu.tw} ; Seng Hock Quak^f ; ^{paeqsh@nus.edu.sg} ; Bee Wah Lee^g ; ^{paeleebw@nus.edu.sg} ; Leen Jan van Doorn^h ; ^{leen-jan.van.doorn@ddl.nl} ; Yee Leong Teoh^b ; ⁱ ; ^{teohyl@yahoo.com} ; Haiwen Tangⁱ ; ^{Haiwen.h.tang@gsk.com} ; P.V. Suryakiranⁱ ; ^{p.v.suryakiran@gsk.com} ; Igor V. Smolenovⁱ ; ^{smolenov@gmail.com} ; Hans L. Bockⁱ ; ^{halubo@yahoo.com} ; Htay Htay Hanⁱ ; ^{htay.h.han@gsk.com}
• 关键词：RVGE ; rotavirus gastroenteritis ; CCID50 ; cell culture infective dose ; ATP ; according-to-protocol cohort ; CI ; confidence interval
• 刊名：Vaccine
• 出版年：2012
• 期刊代码：89_0264410x
• 类别：imm
• 出版时间：22 June, 2012
• 卷：30
• 期：30
• 页码：4552-4557
• 文件大小：360 K

摘要

RIX4414 (Rotarix鈩?, has shown high efficacy during the first 2-years of life. A 2-year randomized, double-blind, placebo-controlled trial in Singapore, Hong Kong, and Taiwan was extended for another year. Infants (6-17 weeks) received 2-doses (1-2 months apart) of RIX4414 (n = 5359) or placebo (n = 5349). During the third-year follow-up, 4359 (RIX4414) and 4328 (placebo) infants were monitored. 64 (1.2%) and 2 (0.04%) infants in the placebo and RIX4414 groups, respectively, reported severe rotavirus-gastroenteritis (RVGE), resulting in a vaccine efficacy of 96.9%(95%CI [88.3-99.6]). Efficacy was 100%(67.5-100) in the third-year. RIX4414 was efficacious against G1 (100.0%[84.8-100]) and pooled non-G1 RV types (94.9%[80.2-99.4]). This study shows that the vaccine is highly efficacious, regardless of circulating RV-types, up to the first 3 years of life in affluent Asian urban populations.