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Study to Assess Efficacy, Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at Different Viral Concentrations in Healthy Infants Previously Uninfected With Human Rotavirus and Approximately 3 Months of Age

Trial Profile

Study to Assess Efficacy, Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at Different Viral Concentrations in Healthy Infants Previously Uninfected With Human Rotavirus and Approximately 3 Months of Age

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Sep 2023

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At a glance

  • Drugs RIX 4414 (Primary)
  • Indications Rotavirus infections
  • Focus Pharmacodynamics
  • 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.
    • 13 Apr 2007 The expected completion date for this trial is now 15 Apr 2003.
    • 05 Mar 2007 New trial record.
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