| September 23, 2004 |
| October 15, 2009 |
| June 2002 |
| May 2009 (final data collection date for primary outcome measure) |
| Tolerability; Incidence of the Composite Endpoint of HPV 16 or HPV 18 Related CIN2/3 or Invasive Cervical Carcinoma After Completion of the Vaccination Series for Relevant HPV Type [ Time Frame: Follow-up through end of study (4 years) ] [ Designated as safety issue: No ] |
| Tolerability; incidence of the composite endpoint of HPV 16 or HPV 18 related CIN2/3 or invasive cervical carcinoma after completion of the vaccination series for relevant HPV type |
| Complete list of historical versions of study NCT00092534 on ClinicalTrials.gov Archive Site |
- Subjects With Anti-HPV 6 Titer >/=20mMU/mL [ Time Frame: week 4 Postdose 3 ] [ Designated as safety issue: No ]
- Subjects With Anti-HPV 11 Titer >/=16mMU/mL [ Time Frame: week 4 Postdose 3 ] [ Designated as safety issue: No ]
- Subjects With Anti-HPV 16 Titer >/=20mMU/mL [ Time Frame: week 4 Postdose 3 ] [ Designated as safety issue: No ]
- Subjects With Anti-HPV 18 Titer >/=24mMU/mL [ Time Frame: week 4 Postdose 3 ] [ Designated as safety issue: No ]
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| serum anti-HPV 6, 11, 16, and 18 >/= 200mMU/mL at week 4 Postdose 3 |
| |
| Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) |
| A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety Immunogenicity and Efficacy on the Incidence of HPV 16/18-Related CIN2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18,) L1 Virus-Like Particle (VLP) Vaccine (V501, Gardasil) in 16- to 23-Year Old Women - The F.U.T.U.R.E. II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease) |
The primary purpose of the study is to determine if Gardasil (V501) an investigational vaccine with 4 components is able to prevent cervical cancer. |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
- Cervical Cancer
- Genital Warts
|
- Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
- Biological: Matching Placebo
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- Experimental: The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
- Placebo Comparator: The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
|
- FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27.
- Garland SM, Steben M, Sings HL, James M, Lu S, Railkar R, Barr E, Haupt RM, Joura EA. Natural History of Genital Warts: Analysis of the Placebo Arm of 2 Randomized Phase III Trials of a Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Vaccine. J Infect Dis. 2009 Jan 26; [Epub ahead of print]
- Barr E, Gause CK, Bautista OM, Railkar RA, Lupinacci LC, Insinga RP, Sings HL, Haupt RM. Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women. Am J Obstet Gynecol. 2008 Mar;198(3):261.e1-11.
- Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007 May 19;369(9574):1693-702.
- Perez G, Lazcano-Ponce E, Hernandez-Avila M, García PJ, Muñoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8.
- FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infect Dis. 2007 Nov 15;196(10):1438-46. Epub 2007 Oct 31.
- Ault KA; Future II Study Group. Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials. Lancet. 2007 Jun 2;369(9576):1861-8.
- Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. Epub 2007 Sep 17.
- Garland SM, Insinga RP, Sings HL, Haupt RM, Joura EA. Human papillomavirus infections and vulvar disease development. Cancer Epidemiol Biomarkers Prev. 2009 Jun;18(6):1777-84.
- Skjeldestad FE, Mehta V, Sings HL, Øvreness T, Turpin J, Su L, Boerckel P, Roberts C, Bryan J, Jansen KU, Esser MT, Liaw KL. Seroprevalence and genital DNA prevalence of HPV types 6, 11, 16 and 18 in a cohort of young Norwegian women: study design and cohort characteristics. Acta Obstet Gynecol Scand. 2008;87(1):81-8.
- Majewski S, Bosch FX, Dillner J, Iversen OE, Kjaer SK, Muñoz N, Olsson SE, Paavonen J, Sigurdsson K, Bryan J, Esser MT, Giacoletti K, James M, Taddeo F, Vuocolo S, Barr E. The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24. J Eur Acad Dermatol Venereol. 2009 Oct;23(10):1147-55. Epub 2009 Apr 23.
- Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Muñoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, Sings HL, James M, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):926-35.
- Wheeler CM, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, García P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Muñoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, James M, Vuocolo S, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):936-44.
|
| |
| Active, not recruiting |
| 12167 |
|
| May 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Healthy women with an intact uterus with lifetime history of 0-4 sexual partners
Exclusion Criteria:
- Prior Human Papilloma Virus (HPV) vaccination
- Prior abnormal Paps
- Prior history of genital warts
|
| Female |
| 16 Years to 23 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00092534 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2004_082, V501-015 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| October 2009 |
