A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women
Phase 2
16 Years
23 Years
16 Years
23 Years
Not Enrolling
Female
Papillomavirus Infections, Genital Diseases, Female
Female
Papillomavirus Infections, Genital Diseases, Female
Trial Information
A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women
Inclusion Criteria:
- Healthy females 16 to 23 years of age
- Not pregnant at enrollment and must have agreed to use effective contraception
through Month 7 of the study
- Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative
sexual intercourse occurred)
Exclusion Criteria:
- No prior receipt of an Human Papillomavirus (HPV) vaccine
- No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment
or receipt of live vaccines within 21 days prior to enrollment
- No prior abnormal Pap test showing squamous intraepithelial lesion (SIL) or biopsy
showing cervical intraepithelial neoplasia (CIN)
- No prior history of genital warts or treatment for genital warts
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Number of Subjects With Injection Site Adverse Experiences
Outcome Time Frame:
Days 1-5 following any vaccination visit
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2006_516
NCT ID:
NCT00365716
Start Date:
May 2000
Completion Date:
September 2009
Related Keywords:
- Papillomavirus Infections
- Genital Diseases, Female
- HPV 6/11/16/18 infection and related genital disease
- Genital Diseases, Female
- Papillomavirus Infections
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