Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092521
First received: September 23, 2004
Last updated: August 26, 2014
Last verified: August 2014

September 23, 2004
August 26, 2014
December 2001
July 2007   (final data collection date for primary outcome measure)
  • Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer [ Time Frame: Follow-up through end of study (4 years) ] [ Designated as safety issue: No ]
  • Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] [ Time Frame: Follow-up through end of study (4 years) ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00092521 on ClinicalTrials.gov Archive Site
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Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)
A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women

The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Cervical Cancer
  • Genital Warts
  • Biological: V501
    Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
    Other Name: V501
  • Biological: Comparator: Placebo
    a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.
  • Biological: Human Papillomavirus (HPV) 16 Monovalent
    HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
  • Experimental: 1
    V501
    Intervention: Biological: V501
  • Placebo Comparator: 2
    Placebo
    Intervention: Biological: Comparator: Placebo
  • Experimental: 3
    HPV 16 Monovalent Vaccine
    Intervention: Biological: Human Papillomavirus (HPV) 16 Monovalent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5759
January 2009
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

  • Prior Human Papillomavirus (HPV) vaccination
  • Prior abnormal paps
  • History of genital warts
Female
16 Years to 23 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00092521
V501-013, 2004_081
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP