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

Infections, Rotavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733862
• Other study ID #: 116929
• Status: Completed
• Start date: November 27, 2012
• Est. completion date: February 8, 2017

Study information

• Verified date: May 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5394
• Est. completion date: February 8, 2017
• Est. primary completion date: February 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1824 Days

Eligibility

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.

Related Conditions & MeSH terms

• Gastroenteritis
• Infections, Rotavirus
• Rotavirus Infections
• Rotavirus Vaccines

Intervention

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.

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.		From Nov 2007 to Oct 2016
Secondary	Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.		From Nov 2007 to Oct 2016
Secondary	Occurrence of RV GE hospitalizations by age group in children less than five years of age.		From Nov 2007 to Oct 2016
Secondary	Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.		From Nov 2007 to Oct 2016
Secondary	Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.		From Nov 2007 to Oct 2016
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Results Summary, Full Protocol and Analysis Plan for study 116929 can be found on the GSK Clinical Study Register