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临床试验/NCT01479491
NCT01479491已完成不适用

Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan

GlaxoSmithKline0 个研究点目标入组 54 人开始时间: 2011年11月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
主要终点
Occurrence of IS in subjects aged < 12 months
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged <12 months after introduction of the Rotarix vaccination in Japan.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
— 至 12 Months（Child）
性别
All
接受健康志愿者
否

入选标准

  • •A male or female infant aged < 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
  • •An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.

排除标准

  • •Not applicable

结局指标

主要结局

Occurrence of IS in subjects aged < 12 months

时间窗: Between January 2005 and April 2011 (6 years)

Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan

时间窗: Between January 2005 and April 2011 (6 years)

次要结局

  • Number of IS cases hospitalized more than once among subjects aged < 12 months.(Between January 2005 and April 2011 (6 years))
  • Occurrence of IS cases by calendar months and year among subjects aged < 12 months(Between January 2005 and April 2011 (6 years))

研究者

申办方类型
Industry
责任方
Sponsor

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