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.
Phase of Trial: Phase III
Latest Information Update: 23 Nov 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
- 23 Nov 2017 Results comparing immunogenecity and safety of HPV-16/18 AS04-adjuvanted vaccine versus two or three doses of 4vHPV vaccine published in the Vaccine.
- 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).