Last updated: 07/17/2024 15:13:58

A study to evaluate immune response and safety of two doses of GSK Biologicals’ HRV liquid vaccine in healthy infants.

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GSK study ID
109216
See study documents
Clinicaltrials.gov ID
NCT00432380
See results summary
EudraCT ID
2015-001544-11
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: Immunogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) liquid vaccine (GSK 357941A) in healthy infants.
Trial description: This study will provide data on the immune response and safety of GSK Biologicals’ HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of seroconverted subjects for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibody

Timeframe: At Month 3

Secondary outcomes:

Number of seroconverted subjects for anti-RV IgA antibody

Timeframe: At Month 3

Serum IgA antibody concentrations against rotavirus

Timeframe: At Month 3

Number of subjects reporting grade 2 or grade 3 fever, vomiting or diarrhea

Timeframe: During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses

Number of subjects reporting any, grade 3 and related solicited general symptoms

Timeframe: During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses

Number of subjects reporting RV in gastroenteritis (GE) episodes

Timeframe: From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3

Number of subjects reporting any unsolicited adverse event (AE)

Timeframe: During the 31-day (Days 0-30) period following any study vaccine dose or placebo

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period (from Day 0 to Month 3)

Interventions:
  • Biological/vaccine: Rotarix™
  • Biological/vaccine: Placebo
    • Enrollment:
    375
    Primary completion date:
    2007-04-09
    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.
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    March 2007 to September 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    5 - 10 weeks
    Accepts healthy volunteers
    Yes
    • Healthy infants between, and including, 5-10 weeks of age
    • at the time of the first dose of HRV liquid vaccine or
    • Use of any investigational or non-registered product
    • (drug or vaccine) other than the study vaccine within
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy infants between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo.
    • Birth weight of the subject should be > 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 study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
    • Planned administration/ administration of a vaccine 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. BCG is administered at birth according to the local EPI.
    • Concurrently participating in another clinical study, at any time during the study period.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    • History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
    • Acute disease at the time of enrolment.
    • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Muntinlupa, Philippines
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-04-09
    Actual study completion date
    2007-04-09

    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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