Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life
Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life
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DOI：
10.1016/j.vaccine.2014.04.079
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发表时间：
2014-08-11
期刊：
影响因子：
5.5
通讯作者：
Bhan, Maharaj Kishan
中科院分区：
文献类型：
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作者：
Bhandari, Nita;Rongsen-Chandola, Temsunaro;Bhan, Maharaj Kishan
轮状病毒胃肠炎是印度2岁以下儿童腹泻的主要原因之一。116E轮状病毒株是作为印度-美国疫苗行动计划的一部分开发的，并已进行了疗效试验。在一项双盲安慰剂对照的多中心试验中，6799名6-7周龄的婴儿随机接受了3剂口服人-牛天然重组疫苗(116E)或安慰剂，分别在6、10和14周。主要结果是严重的轮状病毒胃肠炎(Vesikari分级为11)。通过积极监测确定疗效、结果和不良事件。我们随机分配了4532名和2267名受试者分别接受疫苗和安慰剂，超过96%的受试者接受了所有三种剂量的疫苗或安慰剂。按方案进行的分析包括4354名疫苗受试者和2187名安慰剂组受试者。疫苗组和安慰剂组每100人年严重RVGE的总发生率分别为1.3和2.9。疫苗对2岁以下儿童重症轮状病毒胃肠炎的有效率为55.1%(95%CI为39.9比66.4；P
Rotavirus gastroenteritis is one of the leading causes of diarrhea in Indian children less than 2 years of age. The 116E rotavirus strain was developed as part of the Indo-US Vaccine Action Program and has undergone efficacy trials. This paper reports the efficacy and additional safety data in children up to 2 years of age.In a double-blind placebo controlled multicenter trial, 6799 infants aged 6-7 weeks were randomized to receive three doses of an oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6, 10, and 14 weeks. The primary outcome was severe (>= 11 on the Vesikari scale) rotavirus gastroenteritis. Efficacy outcomes and adverse events were ascertained through active surveillance. We randomly assigned 4532 and 2267 subjects to receive vaccine and placebo, respectively, with over 96% subjects receiving all three doses of the vaccine or placebo. The per protocol analyses included 4354 subjects in the vaccine and 2187 subjects in the placebo group. The overall incidence of severe RVGE per 100 person years was 1.3 in the vaccine group and 2.9 in the placebo recipients. Vaccine efficacy against severe rotavirus gastroenteritis in children up to 2 years of age was 55.1% (95% CI 39.9 to 66.4; p