A phase IIIb open, randomized multi-center study to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to an alternative dosing schedule at, 0, 1 and 12 months as compared to the standard dosing schedule at 0, 1 and 6 months in young healthy female subjects aged 15-25 years.

Trial Profile

A phase IIIb open, randomized multi-center study to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to an alternative dosing schedule at, 0, 1 and 12 months as compared to the standard dosing schedule at 0, 1 and 6 months in young healthy female subjects aged 15-25 years.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 May 2017

At a glance

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

    • 21 Mar 2012 Official title amended as reported by European Clinical Trials Database.
    • 01 May 2009 Actual patient number (805) added as reported by ClinicalTrials.gov.
    • 01 May 2009 Actual initiation date (Feb 2009) added as reported by ClinicalTrials.gov.
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