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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2023

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At a glance

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

    • Most Recent Events

    • 15 Feb 2020 Results of pooled analysis from nine studies including this study published in the Journal of Infectious Diseases.
    • 28 Jan 2010 Results were published in the New England Journal of Medicine.
    • 28 Jan 2010 Results presented in a GlaxoSmithKline Biologicals media release.

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