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
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 |
Verified date | May 2019 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Japan,
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
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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