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
16 Years
23 Years
Female
Cervical Cancer, Genital Warts
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer
Outcome Time Frame:
Follow-up through end of study (4 years)
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2004_081
NCT ID:
NCT00092521
Start Date:
December 2001
Completion Date:
August 2008
Related Keywords:
- Cervical Cancer
- Genital Warts
- Uterine Cervical Neoplasms
- Condylomata Acuminata
- Warts
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
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