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

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.

Study Overview

• Status: Completed
• Conditions: Infections, Rotavirus; Rotavirus Vaccines
• Intervention / Treatment: Other: Data collection

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 Type: Observational
• Enrollment (Actual): 5394

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan, 466-8650
    • GSK Investigational Site
  • Aichi, Japan, 457-8511
    • GSK Investigational Site
  • Aichi, Japan, 457-8510
    • GSK Investigational Site
  • Aichi, Japan, 457-85
    • GSK Investigational Site
  • Aichi, Japan, 466-86
    • GSK Investigational Site
  • Aichi, Japan, 468-8520
    • GSK Investigational Site
  • Aichi, Japan, 468-85
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include 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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Data 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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 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 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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Yoshikawa T, Matsuki T, Sato K, Mizuno M, Shibata M, Hasegawa S, Morita M, Iwasa M, Gopala K, Holl K. Impact of rotavirus vaccination on the burden of acute gastroenteritis in Nagoya city, Japan. Vaccine. 2018 Jan 25;36(4):527-534. doi: 10.1016/j.vaccine.2017.12.006. Epub 2017 Dec 13.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2012
• Primary Completion (Actual): February 8, 2017
• Study Completion (Actual): February 8, 2017

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: November 21, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Vaccination; Japan; Hospitalizations; Impact; Rotavirus gastroenteritis
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Reoviridae Infections; Gastroenteritis; Rotavirus Infections
• Other Study ID Numbers: 116929