At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 12,167 enrolled
Drug / intervention
Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine +1 morebiological
Likely dose
Gardasil 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6AI-extracted
Key inclusion· 3
- ✓Healthy women aged 16-23 years old
- ✓Intact uterus
- ✓Lifetime history of 0-4 sexual partners
Key exclusion· 3
- ✕Prior human papillomavirus (HPV) vaccination
- ✕Prior abnormal Pap smears
- ✕Prior history of genital warts
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine and Matching Placebo for Cervical Cancer and Genital Warts. Completed, enrolled 12,167 participants.
Detailed Summary
The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Genital Warts
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2002
First PostedSep 2004
Primary CompletionJul 2007
Study CompletionJun 2025
TodayJul 2026
First PostedSep 28, 2004
Enrollment StartJun 14, 2002
Primary CompletionJul 31, 2007
Study CompletionJun 13, 2025
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 21.8 years ago
Interventions
Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccinebiological
A 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.
Matching Placebobiological
A placebo 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.