A Phase II Study to Assess the Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix) Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 25 Years.

Trial Profile

A Phase II Study to Assess the Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix) Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 25 Years.

Completed
Phase of Trial: Phase II

Latest Information Update: 19 May 2017

At a glance

  • Drugs AS04A (Primary) ; Human papillomavirus vaccine recombinant bivalent Japan Vaccine/MedImmune (Primary)
  • Indications Cervical cancer; Human papillomavirus infections
  • Focus Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 14 Apr 2011 Status changed from active, no longer recruiting to completed, as reported by ClinicalTrials.gov.
    • 01 Jul 2010 Final results reported in International Journal of Gynecological Cancer,
    • 01 Jul 2010 Primary endpoint 'Vaccine protective efficacy' has been met.
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