Last updated: 11/03/2018 09:29:35

Year 3 extension for efficacy follow-up in subjects vaccinated in studies rota-028, 029 or 030 (NCT00197210)

GSK study ID
107070
Clinicaltrials.gov ID
EudraCT ID
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: A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants.
Trial description: This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the following schedules:
at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or rota-030.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of subjects with severe rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strains

Timeframe: From Year 2 up to Year 3

Secondary outcomes:

Number of subjects reporting serious adverse events (SAEs)

Timeframe: From the end of the primary study up to Year 3

Interventions:
  • Biological/vaccine: Rotarix™
  • Biological/vaccine: Placebo
  • Enrollment:
    8687
    Primary completion date:
    2008-17-07
    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)
    January 2007 to July 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    2 - 3 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
    • A male or female between, and including, 6 and 12 weeks of age in Hong Kong and Taiwan or 11 to 17 weeks of age in Singapore at the time of the first vaccination according to the country recommendations for the routine vaccination schedules.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Singapore, Singapore, 308433
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 119074
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 228510
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 229899
    Status
    Study Complete

    Study documents

    Clinical study report
    Available language(s): English

    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
    2008-17-07
    Actual study completion date
    2008-17-07

    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

    Participate in clinical trial
    Additional information
    Reference to the Primary Study NCT number
    Click here
    Access to clinical trial data by researchers
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