A Phase IIIb observer-blind, randomized, multicentre primary immunization study to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine and Merck's Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, when administered intramuscularly according to alternative 2-dose schedules in 9-14 year old healthy females.

Trial Profile

A Phase IIIb observer-blind, randomized, multicentre primary immunization study to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine and Merck's Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, when administered intramuscularly according to alternative 2-dose schedules in 9-14 year old healthy females.

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2017

At a glance

  • Drugs Human papillomavirus vaccine recombinant bivalent Japan Vaccine/MedImmune (Primary) ; Human papillomavirus vaccine recombinant quadrivalent Merck
  • Indications Cervical cancer; Human papillomavirus infections
  • Focus Pharmacodynamics; Therapeutic Use
  • Acronyms HPV-071-PRI
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals
  • Most Recent Events

    • 25 Feb 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 30 Sep 2013 New source identified and integrated (European Clinical Trials Database : EudraCT2011-002035-26).
    • 15 Nov 2012 Planned End Date changed from 1 Jan 2015 to 1 Dec 2015 as reported by as reported by ClinicalTrials.gov.
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