A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004)
NCT ID: NCT06688058
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2024-12-20
2026-11-30
Brief Summary
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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 V540D) 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 V540D in healthy adults and if people tolerate it.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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V540D
Participants will receive vaccinations with V540D.
V540D
Experimental vaccine and adjuvant administered via intramuscular (IM) injection
GARDASIL®9
Participants will receive vaccinations with GARDASIL®9.
GARDASIL®9
Suspension administered via IM injection
Interventions
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V540D
Experimental vaccine and adjuvant administered via intramuscular (IM) injection
GARDASIL®9
Suspension administered via IM injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Has a history of cancer (malignancy)
* Has received any HPV vaccine or is expected to receive any HPV vaccine during the study, outside the protocol
18 Years
45 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Research Centers of America ( Hollywood ) ( Site 0001)
Hollywood, Florida, United States
Velocity Clinical Research, Savannah ( Site 0005)
Savannah, Georgia, United States
Alliance for Multispecialty Research, LLC ( Site 0003)
Kansas City, Missouri, United States
Alliance for Multispecialty Research, LLC ( Site 0004)
Knoxville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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V540D-004
Identifier Type: -
Identifier Source: org_study_id
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