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Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later. A standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540B) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540B in healthy adults and if people tolerate it.
Official title: A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540B in Healthy Adults.
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2024-11-12
Completion Date
2026-11-20
Last Updated
2025-08-03
Healthy Volunteers
Yes
Conditions
Interventions
GARDASIL®9 (G9)
Suspension administered via intramuscular (IM) injection
V540B
Experimental vaccine and adjuvant administered via IM injection
Locations (5)
Anaheim Clinical Trials ( Site 0002)
Anaheim, California, United States
California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)
Glendale, California, United States
Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale, Florida, United States
Research Centers of America ( Hollywood ) ( Site 0001)
Hollywood, Florida, United States
Velocity Clinical Research, Omaha ( Site 0005)
Omaha, Nebraska, United States