Skip to main content
OpenTrials
Completed

NCT Number: NCT01733862

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infections, Rotavirus Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Rotavirus Vaccines Stomatognathic Diseases Tooth Diseases Tooth, Impacted Virus Diseases

Age range

Up to 1824 day

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Aichi, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

  1. Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.

    Time frame: From Nov 2007 to Oct 2016

Secondary outcomes

  1. Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.

    Time frame: From Nov 2007 to Oct 2016

  2. Occurrence of RV GE hospitalizations by age group in children less than five years of age.

    Time frame: From Nov 2007 to Oct 2016

  3. Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.

    Time frame: From Nov 2007 to Oct 2016

  4. Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.

    Time frame: From Nov 2007 to Oct 2016

  5. Occurrence of outpatient visits for RV GE among all outpatient visits in children less than five years of age.

    Time frame: From Nov 2007 to Oct 2016

  6. Occurrence of outpatient visits for RV GE among AGE outpatient visits in children less than five years of age.

    Time frame: From Nov 2007 to Oct 2016

  7. Duration of hospitalizations for RV GE or AGE, overall, for each year, season in children less than five years of age.

    Time frame: From Nov 2007 to Oct 2016

  8. Occurrence of hospitalizations for RV GE among all emergency visits for RV GE in children less than five years of age.

    Time frame: From Nov 2007 to Oct 2016

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Study to Assess the Impact of Rotavirus Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis (RV GE) in Japan

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 27, 2012
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.