Last updated: 01/25/2019 09:10:22
Study to assess the impact of vaccination on hospitalizations and outpatient visits due to rotavirus gastroenteritis
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study to assess the impact of rotavirus vaccination on hospitalizations and outpatient visits due to rotavirus gastroenteritis (RV GE) in Japan
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of RV GE hospitalizations among all hospitalized children aged less than five years.
Timeframe: From Nov 2007 to Oct 2016
Secondary outcomes:
Occurrence of RV GE hospitalizations among AGE hospitalizations in children less than five years of age.
Timeframe: From Nov 2007 to Oct 2016
Occurrence of RV GE hospitalizations by age group in children less than five years of age.
Timeframe: From Nov 2007 to Oct 2016
Occurrence of AGE hospitalizations among all hospitalized children aged less than five years.
Timeframe: From Nov 2007 to Oct 2016
Occurrence of outpatient visits for AGE among all outpatient visits in children less than five years of age.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: From Nov 2007 to Oct 2016
Interventions:
Enrollment:
5394
Primary completion date:
2017-08-02
Observational study model:
Ecologic or Community
Time perspective:
Retrospective
Clinical publications:
Yoshikawa T et al. (2017) Impact of rotavirus vaccination on the burden of acute gastroenteritis in Nagoya city, Japan. Vaccine. 36(4):527-534. doi: 10.1016/j.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
November 2012 to February 2017
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable - 1824 days
Accepts healthy volunteers
No
- Children aged less than five years visiting hospitals for RV GE or AGE from 2007 to 2016, who live in the study area.
- Not applicable.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2017-08-02
Actual study completion date
2017-08-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
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Additional information
Results Summary, Full Protocol and Analysis Plan for study 116929 can be found on the GSK Clinical Study Register
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