Multi-center study to assess the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants

Trial Profile

Multi-center study to assess the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2016

At a glance

  • Drugs RIX 4414 (Primary)
  • Indications Gastroenteritis; Rotavirus infections
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 28 Jan 2010 Results were published in the New England Journal of Medicine.
    • 28 Jan 2010 Results presented in a GlaxoSmithKline Biologicals media release.
    • 25 Aug 2009 Actual end date changed from Jun 2008 to Jan 2009 as reported by ClinicalTrials.gov.
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