Last updated: 11/04/2018 02:42:52

Evaluate safety & immunogenicity of 2 or 3 doses of GSK HRV vaccine in healthy infants in South Africa

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GSK study ID
444563/013
See study documents
Clinicaltrials.gov ID
NCT00383903
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 phase II, randomized, double-blind, placebo-controlled study of safety, reactogenicity and immunogenicity of 2 or 3 doses of GSK Biologicals’ oral live attenuated human rotavirus vaccine at 10E6.5 CCID50 viral concentration in healthy infants (approximately 5-10 weeks old) in the Republic of South Africa
Trial description: The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: HRV vaccine
    • Enrollment:
    472
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Steele AD et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine Rotarix™ (RIX4414) in South African infants. Abstract presented at the 9th dsRNA Virus Meeting. Cape Town, South Africa, 21-26 Oct 2006.
    Steele AD et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine Rotarix™ (RIX4414) in South African infants. Abstract presented at ASCOOD. Bangkok, Thailand, 8-10 March 2006.
    Steele AD et al. Difference in immune responses between 2 different regimens of RIX4414 ( 106.5 CCID50 viral concentration) in South Africa. Abstract presented at the 4th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Warsaw, Poland, 01-04 Sept 2005.
    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]
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    September 2003 to September 2004
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    5 - 10 weeks
    Accepts healthy volunteers
    Yes
    • Healthy infants born after a normal gestation period (>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject’s mother.
    • Written informed consent was obtained from the parent/guardian of the subject before study entry.
    • History of allergic disease/polio disease,
    • Confirmed or suspected immunosuppressive or immunodeficient condition,
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy infants born after a normal gestation period (>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject’s mother.
    • Written informed consent was obtained from the parent/guardian of the subject before study entry.
    Exclusion criteria:
    • History of allergic disease/polio disease,
    • Confirmed or suspected immunosuppressive or immunodeficient condition,
    • Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator,
    • Received treatment prohibited by the protocol.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Sunnyside, Pretoria, South Africa, 2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brits, South Africa, 0250
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pretoria North, South Africa, 2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rooihuiskraal, South Africa, 0145
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ga-Rankuwa, South Africa, 0208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pretoria, South Africa, 2
    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
    2004-30-09

    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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