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| Descriptive Information Fields | |||||
| Brief Title † | A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501) in Women | ||||
| Official Title † | Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study | ||||
| Brief Summary | This study is to assess the tolerability and efficacy of a vaccine being evaluated to reduce the incidence of human papillomavirus (HPV) infection and disease (external genital warts and vulvar, vaginal, and cervical cancer) in women. |
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| Detailed Description | The duration of treatment is 9 months. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Combined incidence of HPV6/11/16/18 related persistent infection, genital warts, VIN, VaIN, vulvar cancer, vaginal cancer, cervical dysplasia, cervical AIS, and cervical cancer through Month 7. | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Healthy Papillomavirus Infection |
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| Intervention † | Biological: V501, Gardasil, human papillomavirus (types 6,11,16,18) recombinant vaccine Biological: Comparator: placebo |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 3800 | ||||
| Start Date † | June 2004 | ||||
| Completion Date | |||||
| Eligibility Criteria † |
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| Gender | Female | ||||
| Ages | 24 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00090220 | ||||
| Organization ID | 2004_013 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Merck | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Merck | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | August 25, 2004 | ||||
| Last Updated Date | July 12, 2006 | ||||