Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants:: a randomised, double-blind, placebo-controlled phase III study
Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants:: a randomised, double-blind, placebo-controlled phase III study
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DOI：
10.1016/s0140-6736(08)60524-3
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发表时间：
2008-04-05
期刊：
影响因子：
168.9
通讯作者：
Bouckenooghe, Alain
中科院分区：
文献类型：
--
作者：
Linhares, Alexandre C.;Velazquez, F. Raul;Bouckenooghe, Alain
背景轮状病毒胃肠炎的发病高峰见于6至24个月大的婴儿。因此，我们的目的是评估口服减毒活人轮状病毒疫苗预防婴儿严重胃肠炎的2年有效性和安全性。方法来自10个拉丁美洲国家的15183名6 - 13周的健康婴儿，以1：1的比例随机分配，在约2和4个月大时接受两次口服剂量的RIX4414或安慰剂，安慰剂对照的III期研究中，随访至约2岁。主要终点是从第二次接种后2周至1岁的疫苗效力。治疗分配对研究者和参与婴儿的父母隐瞒。从第2次给药后2周至约2岁期间对胃肠炎发作进行疗效随访。根据方案进行分析。该研究在www.example.com注册，编号NCT 00140673（eTrack444563 - 023）。病例减少（p
Background Peak incidence of rotavirus gastroenteritis is seen in infants between 6 and 24 months of age. We therefore aimed to assess the 2-year efficacy and safety of an oral live attenuated human rotavirus vaccine for prevention of severe gastroenteritis in infants.Methods 15183 healthy infants aged 6-13 weeks from ten Latin American countries randomly assigned in a 1 to 1 ratio to receive two oral doses of RIX4414 or placebo at about 2 and 4 months of age in a double-blind, placebo-controlled phase III study were followed up until about 2 years of age. Primary endpoint was vaccine efficacy from 2 weeks after dose two until 1 year of age. Treatment allocation was concealed from investigators and parents of participating infants. Efficacy follow-up for gastroenteritis episodes was undertaken from 2 weeks after dose two until about 2 years of age. Analysis was according to protocol. This study is registered with ClinicalTrials.gov, number NCT00140673 (eTrack444563-023).Findings 897 infants were excluded from the according-to-protocol analysis. Fewer cases (p