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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01733862
Other study ID # 116929
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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