Status:
COMPLETED
Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
Up to 5 years
Brief Summary
The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis. This ...
Eligibility Criteria
Inclusion
- All subjects must satisfy ALL the following criteria at study entry:
- Child aged ≤5 years with opportunity to receive lyophilised or liquid formulation of Rotarix™;
- Hospitalised at one of the participating centres in Belgium;
- A stool sample has been provided for a rotavirus detection test during the study period;
- Laboratory test result of rotavirus is available.
Exclusion
- • None.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01435967
Start Date
September 1 2011
End Date
September 1 2014
Last Update
March 9 2015
Active Locations (8)
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1
GSK Investigational Site
Antwerp, Belgium, 2020
2
GSK Investigational Site
Bonheiden, Belgium, 2820
3
GSK Investigational Site
Charleroi, Belgium, 6000
4
GSK Investigational Site
Ghent, Belgium, 9000