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
Not Enrolling
Female
Cervical Cancer, Genital Warts

Thank you

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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