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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2023

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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; GSK

    • Most Recent Events

    • 03 Oct 2020 Results assessing levels of HPV16 antibodies were related to the levels of the cross-reactive antibodies in population-based cohorts (FUTURE-II and PATRICIA) published in the Journal of Infectious Diseases
    • 05 Sep 2020 Results of pooled analysis of data from 2 trials (NCT00128661 and NCT00122681) published in the Journal of Infectious Diseases
    • 07 Nov 2019 Results of pooled analysis of PATRICIA and CVT data published in the Journal of the National Cancer Institute

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