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V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)
Sponsor: Merck Sharp & Dohme LLC
Summary
This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a non-inferiority margin of 0.67 in the GMT ratio (girls vs. women) for each HPV type.
Official title: A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of a 9vHPV Vaccine (V503) in Chinese Girls 9 Through 14 Years of Age With a Comparison to 3-Dose Regimen of V503 in Chinese Women 20 Through 26 Years of Age
Key Details
Gender
FEMALE
Age Range
9 Years - 26 Years
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2022-07-22
Completion Date
2029-08-03
Last Updated
2022-09-02
Healthy Volunteers
Yes
Conditions
Interventions
9vHPV vaccine
A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.
Locations (2)
Jiangshan Center for Disease Control and Prevention ( Site 0001)
Quzhou, Zhejiang, China
Yuhuan Center for Disease Control and Prevention ( Site 0002)
Taizhou, Zhejiang, China