Last updated: 11/04/2018 02:41:42

Assess efficacy, immune response & safety of 2 doses of oral live attenuated HRV vaccine in healthy infants

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GSK study ID
444563/004
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Clinicaltrials.gov ID
NCT00425737
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 study to assess the efficacy, immunogenicity and safety of two doses of oral live attenuated human rotavirus (HRV) vaccine (Rotarix) in healthy infants.
Trial description: To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Rotarix
    • Enrollment:
    405
    Primary completion date:
    2001-31-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    De Vos B et al. (2004) A Rotavirus Vaccine for Prophylaxis of Infants Against Rotavirus Gastroenteritis. Pediatr Infect Dis J. 23(10):S179-S182.
    De Vos B et al. (2009) Live Attenuated Human Rotavirus Vaccine, RIX4414, Provides Clinical Protection in Infants Against Rotavirus Strains With and Without Shared G and P Genotypes: Integrated Analysis of Randomized Controlled Trials. Pediatr Infect Dis J. 28(4):261-266.
    Soriano-Gabarró M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1):28-32.
    Vesikari T et al. (2003) Efficacy of oral human rotavirus vaccine in infants against acute rotavirus gastroenteritis in the community determined with rotavirus antigen detection by EIA and rotavirus RT-PCR as end points. J Clin Virol. 27(1):8 (Abstract n° 24).
    Vesikari T et al. (2004) Efficacy of RIX4414 Live Attenuated Human Rotavirus Vaccine in Finnish Infants. Pediatr Infect Dis J. 23(10):937-943.
    Vesikari T et al. (2006) A short report on highlights of world-wide development of RIX4414: an European experience. Vaccine. 24(18):3779.
    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]
    De Vos B et al. (2004) A Rotavirus Vaccine for Prophylaxis of Infants Against Rotavirus Gastroenteritis. Pediatr Infect Dis J. 23(10):179-182.
    Medical condition
    Infections, Rotavirus
    Product
    Rotavirus Vaccine
    Collaborators
    Not applicable
    Study date(s)
    August 2000 to June 2002
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 12 weeks
    Accepts healthy volunteers
    Yes
    • Healthy infants 6 and 12 weeks of age at the time of the first vaccination.
    • Written informed consent obtained from the parents
    • Use of any investigational or non-registered drug or vaccine
    • other than the study vaccine within 30 days preceding the study
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy infants 6 and 12 weeks of age at the time of the first vaccination.
    • Written informed consent obtained from the parents or guardians of the subject.
    • Born after a normal gestation period (between 36 and 42 weeks).
    Exclusion criteria:
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
    • Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
    • Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
    • Any clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
    • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
    • Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
    • Household contact with an immunosuppressed individual or pregnant woman.
    • Abnormal stool pattern.
    • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
    • Previous confirmed occurrence of rotavirus gastroenteritis.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    2001-31-07
    Actual study completion date
    2002-26-06

    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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