NCT01636193已完成不适用
Drug Use Investigation for ROTARIX
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,607
- 主要终点
- Occurrence of Adverse events under clinical practice.
研究概览
简要总结
This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.
详细描述
This is non-interventional study conducted in one group received Oral Rotarix®. This surveillance is abbreviated as SMILER (Surveillance and Monitoring In Living clinical Experience for Rotarix).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.
排除标准
- •All infants included in the special drug use investigation of Oral Rotarix will be excluded.
结局指标
主要结局
Occurrence of Adverse events under clinical practice.
时间窗: During the 31-day observation period after each vaccination.
Occurrence of typical symptoms of intussusceptions and bloody stool.
时间窗: During the 31-day observation period after each vaccination.
次要结局
未报告次要终点
研究者
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