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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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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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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.
時間枠：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Data collectionの臨床試験
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IRCCS National Neurological Institute "C. Mondino...IRCCS Associazione Oasi Maria SS. ONLUS, Troina, Italy; IRCCS Istituto Auxologico Italiano,... と他の協力者完了
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Cliniques universitaires Saint-Luc- Université...Université de Liège募集
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Xim LimitedPortsmouth Hospitals NHS Trust; Mind Over Matter Medtech Ltd完了
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The Institute of Molecular and Translational Medicine...Cancer Research Czech Republic完了