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A phase IV, observer-blind, randomized, controlled, multicentric study to assess the safety and immunogenicity of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine (CervarixTM) administered intramuscularly according to a three-dose schedule (Day 0, Week 6, Month 6) in human immunodeficiency virus-infected (HIV+) female subjects aged 15 - 25 years, as compared to Mercks HPV-6/11/16/18 vaccine (Gardasil).

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A phase IV, observer-blind, randomized, controlled, multicentric study to assess the safety and immunogenicity of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine (CervarixTM) administered intramuscularly according to a three-dose schedule (Day 0, Week 6, Month 6) in human immunodeficiency virus-infected (HIV+) female subjects aged 15 - 25 years, as compared to Mercks HPV-6/11/16/18 vaccine (Gardasil).

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 04 Sep 2023

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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 Adverse reactions; Pharmacodynamics
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 02 Jun 2015 Planned number of patients changed from 600 to 708 as reported by ClinicalTrials.gov
    • 02 Jun 2015 Planned End Date changed from 1 Dec 2016 to 1 May 2017 as reported by ClinicalTrials.gov.
    • 02 Jun 2015 Planned primary completion date changed from 1 Dec 2016 to 1 Dec 2015 as reported by ClinicalTrials.gov.

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