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NOT YET RECRUITING
NCT07785843
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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

BIOLOGICAL

Placebo

Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6