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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01733862
Enrollment
5394
Registered
2012-11-27
Start date
2012-11-27
Completion date
2017-02-08
Last updated
2019-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Rotavirus, Rotavirus Vaccines

Keywords

Impact, Vaccination, Hospitalizations, Rotavirus gastroenteritis, Japan

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.

Interventions

OTHERData collection

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.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1824 Days
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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
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 RV GE hospitalizations among AGE hospitalizations 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 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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026