Status:
COMPLETED
Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cervical Cancer
Genital Warts
Eligibility:
All Genders
10-23 years
Phase:
PHASE3
Brief Summary
The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adole...
Eligibility Criteria
Inclusion
- Healthy adolescents and pre-adolescents with no prior sexual history
- Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners
Exclusion
- Prior Human Papillomavirus (HPV) vaccination
- Prior abnormal Paps
- Prior history of genital warts
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
3055 Patients enrolled
Trial Details
Trial ID
NCT00092495
Start Date
December 1 2002
End Date
February 1 2009
Last Update
January 13 2015
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