Last updated: 02/20/2024 08:50:36

Meta-analysis of Rotarix vaccine effectiveness

GSK study ID
206784
See study documents
Clinicaltrials.gov ID
Not applicable
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: Meta-analysis of Rotarix vaccine effectiveness
Trial description: The purpose of this study is to assess the vaccine effectiveness (VE) of Rotarix vaccine based on the evidence collected between 01 January 2006 and 07 July 2016. This study plans to perform a meta-analysis on the Rotarix vaccine effectiveness using all published data.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Laboratory confirmed Rotavirus (RV) infection after referral to hospitals or emergency departments (ED) of children with gastro-enteritis (GE) diseases

Timeframe: Between 01 January 2006 and 07 July 2016

Secondary outcomes:

To assess the VE of HRV per pre-defined subgroup/endpoint

Timeframe: Between 01 January 2006 and 07 July 2016

Interventions:
  • Other: No Intervention
    • Enrollment:
    1
    Primary completion date:
    2017-22-02
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Gastroenteritis
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    January 2017 to February 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    - 5Years
    Accepts healthy volunteers
    None
    • Studies included in this meta-analysis:
    • Observational studies (no clinical trial);
    • All studies which do not fit with the inclusion criteria
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Studies included in this meta-analysis:
    • Observational studies (no clinical trial);
    • Studies assessing direct VE (no impact study);
    • Paediatric studies including children until 5 years old;
    • Birth cohort eligible for RV vaccination;
    Exclusion criteria:
    • All studies which do not fit with the inclusion criteria

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    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
    2017-22-02
    Actual study completion date
    2017-22-02

    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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