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| Descriptive Information Fields | |
| Brief Title † | Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil) |
| 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 |
| Brief Summary | 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. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type † | Interventional |
| Study Design † | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Primary Outcome Measure † | Vaccine type(s)-related external genital wart disease and/or CIN (any grade), AIS; vaccine HPV type related cervical, vulvar and vaginal cancer. |
| Secondary Outcome Measure † | Robust immune response |
| Condition † | Cervical Cancer Genital Warts |
| Intervention † | Biological: V501, Gardasil, human papillomavirus (types 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Active, not recruiting |
| Enrollment † | 5700 |
| Start Date † | December 2001 |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Female |
| Ages | 16 Years to 23 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00092521 |
| Organization ID | 2004_081 |
| Secondary IDs †† | |
| Study Sponsor † | Merck |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Merck |
| Verification Date | September 2005 |
| First Received Date † | September 23, 2004 |
| Last Updated Date | July 12, 2006 |