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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Rotavirus Vaccines; Infections, Rotavirus

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01733862

116929

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,394 patients

Sex: All

Ages: Under 1824 days old

Volunteers: No Healthy Volunteers

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.

Trial design

5,394 participants in 1 patient group

Group Japan

Description:

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.

Treatment:

Other: Data collection