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临床试验/NCT01733862
NCT01733862已完成不适用

A Study to Assess the Impact of Rotavirus Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis (RV GE) in Japan

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 5,394 人开始时间: 2012年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,394
试验地点
1
主要终点
Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.

研究概览

简要总结

This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City (administrative district), Japan, where RV vaccines have been introduced since November 2011 and financial support for vaccination costs by Nagoya city, Japan have been implemented from October 2012.

详细描述

The electronic admission database or any other applicable database of the hospital will be reviewed to identify hospitalized children/children with outpatient visits/emergency room visits, less than five years of age who had been diagnosed with acute gastroenteritis (AGE) or RV GE either by the International Classification of Diseases and Related Health Problems 10th Revision (ICD 10) diagnostic code (AA00-AA09 for intestinal infectious diseases and A08.0 for RV specific GE) or by RV positive rapid diagnosis kit results.

Note: The outcomes for the outpatient and emergency room visits will be assessed only in case the data for outpatient and emergency room visits can be obtained from at least one of the study centers.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Retrospective

入排标准

年龄范围
— 至 1824 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged less than five years visiting hospitals for RV GE or AGE from 2007 to 2016, who live in the study area.

排除标准

  • Not applicable.

结局指标

主要结局

Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.

时间窗: From Nov 2007 to Oct 2016

次要结局

  • Occurrence of outpatient visits for RV GE among all outpatient visits in children less than five years of age.(From Nov 2007 to Oct 2016)
  • Occurrence of hospitalizations for RV GE among all emergency visits for RV GE in children less than five years of age.(From Nov 2007 to Oct 2016)
  • Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.(From Nov 2007 to Oct 2016)
  • Occurrence of outpatient visits for RV GE among AGE outpatient visits in children less than five years of age.(From Nov 2007 to Oct 2016)
  • Duration of hospitalizations for RV GE or AGE, overall, for each year, season in children less than five years of age.(From Nov 2007 to Oct 2016)
  • Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.(From Nov 2007 to Oct 2016)
  • Occurrence of RV GE hospitalizations by age group in children less than five years of age.(From Nov 2007 to Oct 2016)
  • Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.(From Nov 2007 to Oct 2016)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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