Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--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 Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease
Inclusion Criteria:
- Females age 16 to 23 years old
- Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to
any scheduled visit
Exclusion Criteria:
- History of vaccination with an HPV vaccine
- History of hepatitis B infection
- History of vaccination with hepatitis B vaccine
- History of genital warts or treatment for genital warts
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2007_576
NCT ID:
NCT00517309
Start Date:
March 2003
Completion Date:
June 2004
Related Keywords:
- Cervical Cancer
- Genital Warts
- Uterine Cervical Neoplasms
- Condylomata Acuminata
- Hepatitis B
Name | Location |
|---|
