Last updated: 11/07/2018 07:10:02
Observational study on rotavirus gastroenteritis epidemiology, impact of lyophilised vs. liquid formulation of Rotarix™
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Observational, ecological, database study on epidemiology of hospitalisations with rotavirus gastroenteritis confirmed in children aged ≤5 years, and any impact in the change from lyophilised to liquid formulation of Rotarix™, in Belgium
Trial description: 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 is planned to be assessed by comparing trends of hospitalisations due to laboratory confirmed rotavirus gastroenteritis in children <=5 years of age, before and after introduction of the liquid formulation of the vaccine in Belgium.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™
Timeframe: up to 2 years post-introduction of liquid formulation of Rotarix™.
Secondary outcomes:
Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region).
Timeframe: up to 2 years post-introduction of liquid formulation of Rotarix™.
Occurrence of rotavirus detected by laboratory tests at a specific time (month and year).
Timeframe: up to 2 years post-introduction of liquid formulation of Rotarix™.
Occurrence of rotavirus detected by various types of rotavirus laboratory tests.
Timeframe: up to 2 years post-introduction of liquid formulation of Rotarix™.
Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population.
Timeframe: up to 2 years post-introduction of liquid formulation of Rotarix™.
Interventions:
Other: Data collection
Enrollment:
1
Observational study model:
Ecologic or Community
Primary completion date:
2014-30-09
Time perspective:
Retrospective
Clinical publications:
Raes M et al (2016) Epidemiological trends for hospital admissions for acute rotavirus gastroenteritis in Belgium following the introduction of routine RV vaccination and the subsequent switch from the lyophilized to liquid formulation of Rotarix. Epidemiol Infect. 1-8. [Epub ahead of print].
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
September 2011 to September 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable - 5 years
Accepts healthy volunteers
No
- 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™;
- None.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
All subjects must satisfy ALL the following criteria at study entry:
Exclusion criteria:
None.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
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
Finalized
Actual primary completion date
2014-30-09
Actual study completion date
2014-30-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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