Last updated: 11/03/2018 08:31:37

To evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Bio HRV liquid vaccine given to infants (Vietnam)

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GSK study ID
105722
See study documents
Clinicaltrials.gov ID
NCT00345956
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: A placebo-controlled study to evaluate the immunogenicity, reactogenicity and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) liquid vaccine, when given to healthy infants, in Vietnam
Trial description: To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Human rotavirus liquid vaccine
    • Enrollment:
    375
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Anh DD et al. (2011) Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix™) oral suspension (liquid formulation) when co-administered with Expanded Program on Immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007. Vaccine. 29(11):2029-2036.
    Anh DD et al. Immunogenicity, Reactogenicity and Safety of the Oral Live Attenuated Human Rotavirus Vaccine RIX4414(Rotarix™) Oral Suspension (Liquid Formulation) in Vietnamese Infants. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to March 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 10 weeks
    Accepts healthy volunteers
    Yes
    • Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of > 2000 grams.
    • Written informed consent obtained from the parent or guardian of the subject.
    • Use of any investigational or non-registered product (drug or vaccine) other than the HRV liquid vaccine or placebo within 30 days preceding the first dose of HRV liquid vaccine or placebo, or planned use during the study period.
    • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of > 2000 grams.
    • Written informed consent obtained from the parent or guardian of the subject.
    Exclusion criteria:
    • Use of any investigational or non-registered product (drug or vaccine) other than the HRV liquid vaccine or placebo within 30 days preceding the first dose of HRV liquid vaccine or placebo, or planned use during the study period.
    • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
    • Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after.
    • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    • History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Nhatrang, Vietnam, 084
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hanoi, Vietnam, 084
    Status
    Study Complete
    Contact us

    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
    Not applicable
    Actual study completion date
    2007-08-03

    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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