Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis

Completed

• Conditions: Rotavirus Vaccines; Infections, Rotavirus
• Interventions: Other: Data collection

• Registration Number: NCT01733862
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-21
• Study Start: 2012-11-27
• Study First Posted: 2012-11-27
• Primary Completion: 2017-02-08
• Study Completion: 2017-02-08
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-29
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5394

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group Japan	Data collection	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.	From Nov 2007 to Oct 2016

Secondary Outcome Measures

Name	Time	Method
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 RV GE among all outpatient visits 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

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Aichi, Japan