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Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity and Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants.

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Trial Profile

Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity and Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Sep 2023

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At a glance

  • Drugs RIX 4414 (Primary)
  • Indications Rotavirus infections
  • Focus Adverse reactions
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 05 Jan 2012 Results published in the Pediatric Infectious Disease Journal.
    • 23 Oct 2008 Actual patient number (1009) added as reported by ClinicalTrials.gov.
    • 01 Apr 2008 GlaxoSmithKline Biologicals reported as trial affiliate by ClinicalTrials.gov.

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