Status:
COMPLETED
A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Human
Papillomavirus Infections
Eligibility:
All Genders
9-15 years
Phase:
PHASE3
Brief Summary
This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).
Detailed Description
The original base protocol (V501-018)(NCT00092547) was extended in amendments V501-018-05 and -06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the base study w...
Eligibility Criteria
Inclusion
- Healthy adolescents and preadolescents with no prior sexual history
Exclusion
- Subjects with compromised immune system or have a history of severe allergic reaction
Key Trial Info
Start Date :
October 8 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
1781 Patients enrolled
Trial Details
Trial ID
NCT00092547
Start Date
October 8 2003
End Date
June 1 2015
Last Update
February 20 2018
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