Last updated: 11/03/2018 10:37:39

Long-term efficacy and safety of subjects approximately 3 years after priming with 2 doses of GSK Bio’s HRV vaccine.

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GSK study ID
109810
See study documents
Clinicaltrials.gov ID
NCT00420316
See results summary
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: To assess long-term efficacy & safety of subjects approximately 3 years after priming with 2 doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (Rotarix) in the primary vaccination study (102247).
Trial description: To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with any rotavirus gastroenteritis (RVGE)

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Secondary outcomes:

Number of subjects with severe rotavirus gastroenteritis (RVGE)

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Number of subjects with any rotavirus gastroenteritis (RVGE) with G1 serotype

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Number of subjects with severe rotavirus gastroenteritis (RVGE) with G1 serotype

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Number of subjects with any rotavirus gastroenteritis (RVGE) with non-G1 serotype

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Number of subjects with severe rotavirus gastroenteritis (RVGE) with non-G1 serotype

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Number of subjects with severe gastroenteritis (GE)

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Number of subjects reporting serious adverse events (SAEs)

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Number of subjects reporting intussusception (IS)

Timeframe: During the period starting from the end of the second follow-up up to the start of the study (up to 6 months)

Interventions:
  • Biological/vaccine: Rotarix (primary vaccination study)
  • Biological/vaccine: Placebo (primary vaccination study)
    • Enrollment:
    1613
    Primary completion date:
    2007-08-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    February 2007 to August 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    32 months - 3 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • A male or female who has completed the second year
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
    • Written informed consent obtained from the parent or guardian of the subject.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Tampere, Finland, 33520
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pori, Finland, 28120
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Vantaa, Finland, 01600
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Jarvenpaa, Finland, 04400
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oulu, Finland, 90100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Seinajoki, Finland, 60100
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 15 Results

    Study documents

    Clinical study report
    Available language(s): English
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    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-08-08
    Actual study completion date
    2007-08-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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