V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071) - Trial NCT05450705
Access comprehensive clinical trial information for NCT05450705 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Not yet recruiting. The study focuses on Papillomavirus Infections. Target enrollment is 1500 participants.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme LLC
Timeline & Enrollment
Phase 3
Jul 22, 2022
Aug 03, 2029
Primary Outcome
Stage I: Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) to 9 vaccine types of 9vHPV vaccine,Stage II: cLIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age,Stage II: cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05450705
Non-Device Trial