Status:
COMPLETED
Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HPV Infections
Eligibility:
FEMALE
20-45 years
Phase:
PHASE3
Brief Summary
A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specifi...
Detailed Description
The Base Study V501-041 duration was 30 months. The study was extended to further evaluate the efficacy of Quadrivalent HPV (Type 6, 11, 16, 18) L1 VLP (qHPV) vaccine against Cervical Intraepithelial ...
Eligibility Criteria
Inclusion
- Healthy women between the ages of 20 and 45
- Have used effective contraception for 2 weeks prior to starting in the study
- Does not have a temperature within 24 hours before the first injection
Exclusion
- Prior history of genital warts
- More than 4 lifetime sexual partners
- Have undergone hysterectomy
- Have active cervical disease or history of cervical disease
Key Trial Info
Start Date :
December 31 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2016
Estimated Enrollment :
3006 Patients enrolled
Trial Details
Trial ID
NCT00834106
Start Date
December 31 2008
End Date
September 30 2016
Last Update
February 4 2019
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