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| Sponsored by: |
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, and genital warts.
| Condition | Intervention | Phase |
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Cervical Cancer Genital Warts |
Biological: V501, Gardasil, human papillomavirus (types 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years |
Phase III |
| MedlinePlus related topics: | Cancer Cervical Cancer Genital Warts Warts |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Study to Evaluate the Efficacy of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, and 18) L1 Virus-Like Particle (VLP) Vaccine in Reducing the Incidence of HPV 6/11-, 16-, and 18-Related CIN and VaIN, and HPV 6/11-, 16-, and 18-Related External Genital Warts and VI |
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
| Study ID Numbers: | 2004_081 |
| First Received: | September 23, 2004 |
| Last Updated: | July 12, 2006 |
| ClinicalTrials.gov Identifier: | NCT00092521 |
| Health Authority: | United States: Food and Drug Administration |
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