Spots Global Cancer Trial Database for V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)
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Trial Identification
Brief Title: V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)
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
Study ID: NCT05450705
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 9 Years
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Jiangshan Center for Disease Control and Prevention ( Site 0001), Quzhou, Zhejiang, China
Yuhuan Center for Disease Control and Prevention ( Site 0002), Taizhou, Zhejiang, China
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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