Last updated: 11/04/2018 02:45:40

Study of 2 doses of HRV vaccine given concomitantly with routine EPI vaccinations including OPV in healthy infants

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GSK study ID
444563/024
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Clinicaltrials.gov ID
NCT00139347
EudraCT ID
2015-001540-10
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 multi-country & multi-center study to assess the efficacy, immunogenicity & safety of two doses of GSK Biologicals' oral live attenuated HRV vaccine given concomitantly with routine EPI vaccinations including OPV in healthy infants
Trial description: The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: 2-dose oral live attenuated G1P[8] human rotavirus vaccine
    • Enrollment:
    6360
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Gonzalez Ayala et al. Co-administration with rotavirus vaccine rix4414 (rotarix™) does not interfere with the immunogenicity of oral polio vaccine (OPV). Poster presented at WSPID Bangkok, Thailand, 15-18 Nov 2007.
    Lopez P et al. Immunogenicity of an Oral Polio Vaccine is Unaffected when Co-Administered with a Human Rotavirus Vaccine RIX4414 (Rotarix™) in Latin America. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.
    Tregnaghi M et al. (2011) Human Rotavirus vaccine is highly efficacious when co-administered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America. Pediatr Infect Dis J. 30(6):103-108.
    Tregnaghi M et al. Oral Human Rotavirus Vaccine RIX4414(Rotarix™) Co-administered with Routine EPI Vaccinations Including Oral Polio Vaccine(OPV) Is Highly Efficacious in Latin-America. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.
    Buyse H et al. (2013) The human rotavirus vaccine Rotarix™ in infants: An integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 10(1). [Epub ahead of print]
    Tregnaghi M et al. (2011) Human Rotavirus vaccine is highly efficacious when coadministered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America. Pediatr Infect Dis J. 30(6):103-108.
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    December 2003 to March 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 12 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
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    Location
    GSK Investigational Site
    Rio Cuarto, Córdova, Argentina, 5800
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cordoba, Argentina, 5000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    David, Chiriquí, Panama, Panamá 937, David
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Panama, Panama
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cali Colombia, Colombia
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cali, Colombia
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 17 Results

    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
    2007-20-03

    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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