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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jun 2015

At a glance

  • Drugs Rotavirus vaccine (Primary)
  • Indications Rotavirus infections
  • Focus Adverse reactions
  • Sponsors GlaxoSmithKline
  • 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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