A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.

Trial Profile

A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Apr 2018

At a glance

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

    • 30 Apr 2018 Results of pooled analysis based on control arms of NCT00128661 and NCT00122681 trials assessing the relationship between baseline naturally acquired HPV-18 antibodies and (1) newly detected HPV-18 infection, (2) newly detected HPV-18 infections that persisted over 12 months, and (3) newly detected HPV-18 infections with concurrent cytological abnormalities published in the Journal of Infectious Diseases
    • 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
    • 20 Oct 2015 Primary endpoint has been met. (Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.), as per an article published in the Journal of the National Cancer Institute
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