Last updated: 11/03/2018 09:39:31

Study of 2 doses of HRV vaccine given concomitantly or separately with routine vaccinations in healthy infants in USA

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GSK study ID
107531
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Clinicaltrials.gov ID
NCT00334607
EudraCT ID
2011-004061-32
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: Assess the immunogenicity of 3 doses of Pediarix®, Prevnar® & ActHIB® given to healthy infants when administered with GSK Biologicals’ 2 dose oral live attenuated human rotavirus vaccine given during the same vaccination visit or separately
Trial description: The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: 2-dose oral live attenuated G1P[8] human rotavirus vaccine
    • Enrollment:
    484
    Primary completion date:
    2007-08-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Dennehy PH et al. (2008) Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics. 122(5):e1062-1066.
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    June 2006 to June 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 16 weeks
    Accepts healthy volunteers
    Yes
    • Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.
    • Allergic reaction to vaccine components;
    • clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.
    Exclusion criteria:
    • Allergic reaction to vaccine components;
    • clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
    • immunocompromised.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bryson, North Carolina, United States, 28713
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Jordan, Utah, United States, 84095
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Benton, Arkansas, United States, 72015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Providence, Rhode Island, United States, 02903
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Deerfield, North Carolina, United States, 28607
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Akron, Ohio, United States, 44304
    Status
    Study Complete
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    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
    2007-08-02
    Actual study completion date
    2007-17-06

    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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