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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Aichi, Japon, 466-8650
- GSK Investigational Site
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Aichi, Japon, 457-8511
- GSK Investigational Site
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Aichi, Japon, 457-8510
- GSK Investigational Site
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Aichi, Japon, 457-85
- GSK Investigational Site
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Aichi, Japon, 466-86
- GSK Investigational Site
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Aichi, Japon, 468-8520
- GSK Investigational Site
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Aichi, Japon, 468-85
- GSK Investigational Site
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.
Délai: From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: From Nov 2007 to Oct 2016
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From Nov 2007 to Oct 2016
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 116929
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