Hospital-based, Case-control Study to Assess the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children Born After 1 March 2006 and at Least 12 Weeks of Age, in Panama

GlaxoSmithKline1 个研究点分布在 1 个国家目标入组 885 人开始时间: 2008年3月19日最近更新: 2017年9月5日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 885
试验地点: 1
主要终点: Occurrence of RV GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which corresponds to the date of introduction of Rotarix™ in the national immunization program.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Prospective

入排标准

年龄范围: 12 Weeks 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Occurrence of RV GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.

次要结局

Occurrence of acute GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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