Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
Phase 3
16 Years
23 Years
16 Years
23 Years
Not Enrolling
Female
Cervical Cancer, Genital Warts
Female
Cervical Cancer, Genital Warts
Trial Information
Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
Inclusion Criteria:
- Female with an intact uterus with lifetime history of 0-4 sexual partners
Exclusion Criteria:
- Prior Human Papillomavirus Vaccine (HPV) vaccination;
- Prior abnormal paps;
- Prior history of genital warts
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Tolerability and immune responses at week 4 post dose 3.
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2004_080
NCT ID:
NCT00092482
Start Date:
April 2002
Completion Date:
June 2004
Related Keywords:
- Cervical Cancer
- Genital Warts
- Uterine Cervical Neoplasms
- Condylomata Acuminata
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