Clinical trial · Interventional
Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)
A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year Old Women - The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
NCT00092534CI-TRIAL-00092970FUTURE IIcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Genital Warts | Condyloma Acuminatum | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine | Biological | — | UNRESOLVED |
| Matching Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Quadrivalent Human Papillomavirus (HPV) Vaccine
- description
- 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.
- interventionNames
- Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Biological: Matching Placebo
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 23 Years
Show eligibility criteria text
Inclusion Criteria for the Base Study: * Healthy women with an intact uterus with lifetime history of 0-4 sexual partners --For Extension Phase: * Participant received placebo or an incomplete vaccination series in the original study --For LTFU: * Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden. * Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection Exclusion Criteria for the Base Study: * Prior Human Papilloma Virus (HPV) vaccination * Prior abnormal Paps * Prior history of genital warts --For Extension Phase: * Prior complete HPV vaccination series * Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil --For LTFU Study: * There were no exclusion criteria that did not overlap the inclusion criteria for this study.
References
Publications (33)
- BACKGROUNDFUTURE 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. doi: 10.1056/NEJMoa061741. PMID 17494925
- BACKGROUNDGarland 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 Mar 15;199(6):805-14. doi: 10.1086/597071. PMID 19199546
- BACKGROUNDBarr 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. doi: 10.1016/j.ajog.2007.09.001. PMID 18313445
- BACKGROUNDJoura 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. doi: 10.1016/S0140-6736(07)60777-6. PMID 17512854
- BACKGROUNDPerez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz 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. doi: 10.1002/ijc.23260. PMID 18000825
- BACKGROUNDFUTURE 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. doi: 10.1086/522864. Epub 2007 Oct 31.