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A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers want to learn if V503 (also called the 9-valent human papillomavirus \[9vHPV\] vaccine, recombinant) can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Chinese females who previously received the bivalent HPV (2vHPV) vaccine. The 9vHPV vaccine protects against diseases caused by 9 types of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58) and the 2vHPV vaccine protects against diseases caused by 2 types of HPV (16 and 18). The goals of the trial are to learn: * If the 9vHPV vaccine can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in participants who received the 2vHPV vaccine * About the safety of the 9vHPV vaccine in prior 2vHPV vaccine recipients
Official title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Immunogenicity and Safety of V503 in Chinese Females Aged 10 to 45 Years Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine
Key Details
Gender
FEMALE
Age Range
10 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
930
Start Date
2026-09-23
Completion Date
2028-12-22
Last Updated
2026-08-25
Healthy Volunteers
Yes
Conditions
Interventions
V503
V503 (9-vHPV vaccine \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\]) administered as a 0.5-mL intramuscular (IM) injection on Day 1, Month 2, and Month 6
Placebo
Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6