Phase IIIb, Double-Blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV-16/18 VLP/AS04 Vaccine Administered Intramuscularly at 0, 1, 6 Months in Healthy Indian Female Subjects Aged 18-35 Yrs.

Trial Profile

Phase IIIb, Double-Blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV-16/18 VLP/AS04 Vaccine Administered Intramuscularly at 0, 1, 6 Months in Healthy Indian Female Subjects Aged 18-35 Yrs.

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Dec 2016

At a glance

  • Drugs Human papillomavirus vaccine recombinant bivalent Japan Vaccine/MedImmune (Primary)
  • Indications Cervical cancer; Human papillomavirus infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 31 Jan 2011 Actual end date changed from Nov 2007 to Dec 2007 as reported by ClinicalTrials.gov.
    • 01 Feb 2010 Results published in the Journal of Obstetrics and Gynaecology Research.
    • 22 Dec 2009 Actual patient number (354) added as reported by ClinicalTrials.gov.
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