Last updated: 11/07/2018 07:10:02

Observational study on rotavirus gastroenteritis epidemiology, impact of lyophilised vs. liquid formulation of Rotarix™

GSK study ID
114061
See study documents
Clinicaltrials.gov ID
NCT01435967
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2014-30-09
    Observational study model:
    Ecologic or Community
    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:

      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 criteria:

      None.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Ieper, Belgium, 8900
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Antwerpen, Belgium, 2020
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bonheiden, Belgium, 2820
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jette, Belgium, 1090
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charleroi, Belgium, 6000
    Status
    Study Complete
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    Showing 1 - 6 of 8 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    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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