A Randomized, Placebo-Controlled, Double-Blind Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine to Investigate the Safety, and Efficacy in Chinese 20 - to 45-Years-Old Women
20 Years
45 Years
Female
HPV Infections
Trial Information
A Randomized, Placebo-Controlled, Double-Blind Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine to Investigate the Safety, and Efficacy in Chinese 20 - to 45-Years-Old Women
The Base Study V501-041 had a planned duration of 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 Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ
(AIS), and/or cervical cancer. The total duration of the study extension is expected to be
approximately 36 months, until the requisite number of primary efficacy endpoint cases (HPV
16/18-related CIN 2 or worse) has accrued over the total study period (base study and
extension).
Inclusion Criteria:
- 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 Criteria:
- Prior history of genital warts
- More than 4 lifetime sexual partners
- Have undergone hysterectomy
- Have active cervical disease or history of cervical disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Number of participants with persistent HPV 6, 11, 16 or 18 infection, or HPV 6/11/16/18-related genital disease
Outcome Time Frame:
Up to Month 30
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
China: Ministry of Health
Study ID:
V501-041
NCT ID:
NCT00834106
Start Date:
January 2009
Completion Date:
February 2015
Related Keywords:
- HPV Infections
- HPV 6/11/16/18 Infection
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