Status:
COMPLETED
Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Papillomavirus Infections
Eligibility:
FEMALE
9-23 years
Phase:
PHASE3
Brief Summary
This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.
Eligibility Criteria
Inclusion
- Girls ages 9 to 15 years (must not yet have had coitarche)
- Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners)
Exclusion
- All Subjects:
- History of known prior vaccination with an HPV vaccine.
- Women Ages 16 to 23 Only:
- Individuals with any prior history of genital warts or treatment for genital warts.
- Individuals with \> 3 lifetime male or female sexual partners.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00157950
Start Date
October 1 2005
End Date
June 1 2006
Last Update
February 4 2016
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