| August 25, 2004 |
| October 29, 2009 |
| June 2004 |
| July 2007 (final data collection date for 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 [ Time Frame: 48 months ] [ Designated as safety issue: No ] |
| 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. |
| Complete list of historical versions of study NCT00090220 on ClinicalTrials.gov Archive Site |
| Combined incidence of HPV6/11 related persistent infection, genital warts, VIN, VaIN, vulvar cancer, vaginal cancer, cervical dysplasia, cervical AIS, and cervical cancer [ Time Frame: 48 months ] [ Designated as safety issue: No ] |
| Same as current |
| |
| A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501) in Women |
| 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 |
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. |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
- Healthy
- Papillomavirus Infection
|
- Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Biological: Comparator: Placebo
|
- Experimental: Gardasil
- Placebo Comparator: Placebo
|
- Muñoz N, Manalastas R Jr, Pitisuttithum P, Tresukosol D, Monsonego J, Ault K, Clavel C, Luna J, Myers E, Hood S, Bautista O, Bryan J, Taddeo FJ, Esser MT, Vuocolo S, Haupt RM, Barr E, Saah A. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial. Lancet. 2009 Jun 6;373(9679):1949-57. Epub 2009 Jun 1.
- Velicer C, Zhu X, Vuocolo S, Liaw KL, Saah A. Prevalence and Incidence of HPV Genital Infection in Women. Sex Transm Dis. 2009 Jul 31; [Epub ahead of print]
|
| |
| Active, not recruiting |
| 3800 |
| March 2011 |
| July 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- No history of HPV infection, surgical treatment to the cervix, or genital warts
Exclusion Criteria:
- Subject is pregnant
- Subject previously received any HPV vaccine
|
| Female |
| 24 Years to 45 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00090220 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2004_013, V501-019 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| October 2009 |