Status:
COMPLETED
Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Papillomavirus Infections
Genital Diseases, Female
Eligibility:
FEMALE
16-23 years
Phase:
PHASE2
Brief Summary
This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating und...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
1158 Patients enrolled
Trial Details
Trial ID
NCT00365716
Start Date
May 1 2000
End Date
September 1 2009
Last Update
October 7 2015
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