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Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092521
First received: September 23, 2004
Last updated: September 24, 2015
Last verified: September 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Cervical Cancer Genital Warts | Biological: V501 Biological: Comparator: Placebo Biological: Human Papillomavirus (HPV) 16 Monovalent | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Vulvar Cancer
Vaginal Cancer
Cervical Intraepithelial Neoplasia
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- 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) ]
- 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) ]
| Enrollment: | 5759 |
| Study Start Date: | December 2001 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
V501
|
Biological: V501
Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
|
|
Placebo Comparator: 2
Placebo
|
Biological: Comparator: Placebo
a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.
|
|
Experimental: 3
HPV 16 Monovalent Vaccine
|
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.
|
Eligibility| Ages Eligible for Study: | 16 Years to 23 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092521
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092521
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00092521 History of Changes |
| Other Study ID Numbers: |
V501-013 2004_081 |
| Study First Received: | September 23, 2004 |
| Results First Received: | August 3, 2009 |
| Last Updated: | September 24, 2015 |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Warts Condylomata Acuminata Cervical Intraepithelial Neoplasia Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Papillomavirus Infections DNA Virus Infections |
Virus Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 21, 2017