A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age

Trial Profile

A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2017

At a glance

  • Drugs Human papillomavirus vaccine recombinant bivalent Japan Vaccine/MedImmune (Primary) ; Alum; AS04A; Hepatitis A vaccine inactivated
  • Indications Adenocarcinoma; Cervical cancer; Cervical intraepithelial neoplasia; Hepatitis A; Human papillomavirus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PATRICIA
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 01 Jan 2017 Results of a pooled analysis evaluating Type Replacement following HPV16/18 vaccination in patients from two randomized controlled trials (CVT and PATRICIA; n=21596) published in the Journal of the National Cancer Institute
    • 09 Nov 2011 Results from a pre-defined exploratory analysis have been published in The Lancet Oncology, according to a GlaxoSmithKline media release.
    • 08 Nov 2011 End-of-study results published in the Lancet Oncology.
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