A Dose-range Study to Assess the Safety and Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-month) in Healthy Adult Females (18-25 Years of Age)

Trial Profile

A Dose-range Study to Assess the Safety and Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-month) in Healthy Adult Females (18-25 Years of Age)

Completed
Phase of Trial: Phase I/II

Latest Information Update: 29 Sep 2016

At a glance

  • Drugs GSK 568893A (Primary) ; AS04A; Human papillomavirus vaccine recombinant bivalent Japan Vaccine/MedImmune
  • Indications Cervical cancer; Cervical intraepithelial neoplasia; Human papillomavirus infections
  • Focus Pharmacodynamics
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 24 Mar 2014 Primary endpoint 'Geometric-mean-antibody-titre' has not been met.
    • 24 Mar 2014 Results published in Vaccine.
    • 12 Jun 2013 Planned number of patients changed from 376 to 383 as reported by ClinicalTrials.gov.
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