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Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)
Sponsor: Merck Sharp & Dohme LLC
Summary
This study will evaluate the efficacy, immunogenicity and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese women 20 to 45 years of age. The primary hypotheses are: 9vHPV vaccine reduces the incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month persistent infection at least 1 month post Dose 3, compared with quadrivalent HPV (qHPV) vaccine in women 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative Day 1 through Month 7 to the relevant HPV type; and 9vHPV vaccine induces non-inferior competitive luminex immunoassay (cLIA) geometric mean titers (GMTs) for each of HPV 6, 11, 16, and 18 one month post Dose 3, compared with qHPV vaccine in women 20 to 45 years of age who are seronegative at Day 1 and PCR negative Day 1 through Month 7 to the relevant HPV type.
Official title: A Phase 3 Randomized, Double-Blinded, Controlled With GARDASIL® Efficacy, Immunogenicity and Safety Study of V503 [a 9-Valent HPV Vaccine] in Chinese Women 20 to 45 Years of Age
Key Details
Gender
FEMALE
Age Range
20 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
6000
Start Date
2019-06-26
Completion Date
2028-03-31
Last Updated
2022-11-16
Healthy Volunteers
Yes
Conditions
Interventions
V503
9vHPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine
Gardasil
qHPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine
Locations (6)
Lingchuan Center for Disease Control and Prevention ( Site 0002)
Guilin, Guangxi, China
Quanzhou Center for Disease Control and Prevention ( Site 0001)
Guilin, Guangxi, China
Xiangyuan Center for Disease Control and Prevention ( Site 0003)
Changzhi, Shanxi, China
Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0004)
Yuncheng, Shanxi, China
Mianyang Center for Disease Control and Prevention ( Site 0005)
Mianyang, Sichuan, China
Santai County Center for Disease Control and Prevention ( Site 0006)
Mianyang, Sichuan, China