Last updated: 10/29/2024 13:00:31
A database study to assess the trends in hospitalisations of children aged <2 years, in Belgium, with confirmed rotavirus gastroenteritis (RV GE) and the impact of switching from initial GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) to GSK’s Porcine circovirus (PCV)-free HRV vaccine
GSK study ID
212535
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: An observational study to assess the trends in confirmed rotavirus gastroenteritis (RV GE) hospitalisations and to assess the impact of the switch from initial to Porcine circovirus (PCV)-free GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus vaccine, in children aged <2 years, in Belgium
Trial description: The aim of this observational, ecological database study is to assess the impact of the switch from the initial GSK’s HRV vaccine to GSK’s PCV-free HRV vaccine on hospitalisations with gastroenteritis that are laboratory confirmed as rotavirus in children aged <2 years, in Belgium. This is planned to be assessed by comparing trends in hospitalisations before and after introduction of GSK’s PCV-free HRV in Belgium. GSK has gradually introduced its PCV-free HRV vaccine for its worldwide HRV vaccine procurement, which was expected to start first in Europe. The use of PCV-free starting materials for the manufacturing of GSK’s HRV vaccine in Europe was approved first by European Medicines Agency (EMA) on 13 February 2020.
Primary purpose:
Prevention
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of laboratory confirmed RV GE in hospitalized children aged <2 years with RV GE testing results available before and after the switch from initial GSK’s HRV vaccine to GSK’s PCV-free HRV vaccine
Timeframe: From 01 June 2007 to 31 May 2021 (14-year duration) and from 01 June 2022 to 31 May 2025 (3-year duration)
Secondary outcomes:
Occurrence of laboratory confirmed RV GE in hospitalized children aged <2 years with RV GE laboratory testing results available before the introduction of initial GSK’s HRV vaccine and after the introduction of GSK’s PCV-free HRV vaccine
Timeframe: From 01 June 2004 to 31 May 2006 (2-year duration) and from 01 June 2022 to 31 May 2025 (3-year duration)
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2025-19-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Gastroenteritis
Product
SB444563
Collaborators
Realidad
Study date(s)
April 2021 to February 2026
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable - 2 Years
Accepts healthy volunteers
No
- Children aged <2 years and born after 01 June 2004.
- Children registered in the electronic databases of selected hospitals.
- Not applicable.
Inclusion and exclusion criteria
Inclusion criteria:
- Children aged <2 years and born after 01 June 2004.
- Children registered in the electronic databases of selected hospitals.
- A stool sample has been provided for a RV detection test and laboratory test result of RV is available during the study period.
Exclusion criteria:
- Not applicable.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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