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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00092521 |
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 III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| Enrollment: | 5759 |
| Study Start Date: | December 2001 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
|
2: Placebo Comparator
Placebo
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Biological: Comparator: Placebo
a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.
|
|
3: Experimental
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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2004_081, V501-013 |
| Study First Received: | September 23, 2004 |
| Results First Received: | August 3, 2009 |
| Last Updated: | January 21, 2010 |
| ClinicalTrials.gov Identifier: | NCT00092521 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Neoplasms Genital Diseases, Female Uterine Cervical Neoplasms Uterine Cervical Diseases Neoplasms by Site Carcinoma in Situ Uterine Neoplasms Neoplasms by Histologic Type Skin Diseases Genital Neoplasms, Female Uterine Diseases |
Cervical Intraepithelial Neoplasia Carcinoma Virus Diseases Skin Diseases, Viral Neoplasms Skin Diseases, Infectious Warts Condylomata Acuminata Sexually Transmitted Diseases Papillomavirus Infections DNA Virus Infections Neoplasms, Glandular and Epithelial |