Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis
A Study to Assess the Impact of Rotavirus Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis (RV GE) in Japan
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Aichi、日本、466-8650
- GSK Investigational Site
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Aichi、日本、457-8511
- GSK Investigational Site
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Aichi、日本、457-8510
- GSK Investigational Site
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Aichi、日本、457-85
- GSK Investigational Site
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Aichi、日本、466-86
- GSK Investigational Site
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Aichi、日本、468-8520
- GSK Investigational Site
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Aichi、日本、468-85
- GSK Investigational Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Children aged less than five years visiting hospitals for RV GE or AGE from 2007 to 2016, who live in the study area.
Exclusion Criteria:
- Not applicable.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Group Japan
Children less than five years of age, hospitalized for RV GE or AGE and children with outpatient or emergency room visits for RV GE or AGE, between November 2007 and October 2016 (i.e., before and after the introduction of RV vaccination in Japan) in any of the selected hospitals.
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Data sheet. Data will be collected and is planned to be analysed at the following time points: Pre-vaccination period: Nov 2007 to Oct 2011, transition period: Nov 2011 to Oct 2012 and post vaccination period: Nov 2012 to Oct 2016. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.
大体时间：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.
大体时间：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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Occurrence of RV GE hospitalizations by age group in children less than five years of age.
大体时间：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.
大体时间：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.
大体时间：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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Occurrence of outpatient visits for RV GE among all outpatient visits in children less than five years of age.
大体时间：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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Occurrence of outpatient visits for RV GE among AGE outpatient visits in children less than five years of age.
大体时间：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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Duration of hospitalizations for RV GE or AGE, overall, for each year, season in children less than five years of age.
大体时间：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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Occurrence of hospitalizations for RV GE among all emergency visits for RV GE in children less than five years of age.
大体时间：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.