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.

Trial Profile

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jan 2017

At a glance

  • Drugs Rotavirus vaccine (Primary)
  • Indications Rotavirus infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline
  • 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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