Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
Launched by MERCK SHARP & DOHME LLC · Jan 30, 2009
Trial Information
Current as of May 28, 2025
Completed
Keywords
ClinConnect Summary
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 Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ (AIS), and/or cervical cancer. The efficacy was followed through the Month 78 visit, and the close-out visit was conducted at approximately Month 90 with only safety data collected
Gender
FEMALE
Eligibility criteria
- 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
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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