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Assess the effect on immunogenicity of administration of vaccine without buffering agent and assess heat stability in terms of immunogenicity, reactogenicity and safety of GSK [GlaxoSmithKline] Biologicals' oral live attenuated human rotavirus vaccine following a 0 2 month schedule in healthy infants previously uninfected with human rotavirus.

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Assess the effect on immunogenicity of administration of vaccine without buffering agent and assess heat stability in terms of immunogenicity, reactogenicity and safety of GSK [GlaxoSmithKline] Biologicals' oral live attenuated human rotavirus vaccine following a 0 2 month schedule in healthy infants previously uninfected with human rotavirus.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Sep 2023

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At a glance

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

    • Most Recent Events

    • 09 Oct 2008 Checked against ClinicalTrials.gov record - last updated 9 Oct 2008.
    • 13 Apr 2007 Results have been reported.
    • 06 Nov 2006 Status change

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