Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).

Part of paid clinical trials in Anaheim, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06623409
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • GARDASIL®9 (G9) — BIOLOGICAL
    Suspension administered via intramuscular (IM) injection
  • V540B — BIOLOGICAL
    Experimental vaccine and adjuvant administered via IM injection

Study Details

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.

Key Dates

First listed
Oct 2, 2024
Start date
Nov 12, 2024
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: GARDASIL®9 (G9)
    Participants will receive vaccinations with G9.
  • Experimental: V540B
    Participants will receive vaccinations with V540B.

Primary Outcome Measure

Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE) [ Time Frame: Up to approximately 6 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Anaheim Clinical Trials ( Site 0002)AnaheimCalifornia92801-
California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)GlendaleCalifornia91206-
Velocity Clinical Research, Hallandale Beach ( Site 0003)HallandaleFlorida33009-
Research Centers of America ( Hollywood ) ( Site 0001)HollywoodFlorida33024
Study Coordinator
954-324-4706
Velocity Clinical Research, Omaha ( Site 0005)OmahaNebraska68134-

Find similar trials in Anaheim, CA

By research site
Anaheim Clinical Trials· Anaheim, CACalifornia Clinical Trials Medical Group managed by PAREXEL· Glendale, CAVelocity Clinical Research, Hallandale Beach· Hallandale, FLResearch Centers of America ( Hollywood )· Hollywood, FLVelocity Clinical Research, Omaha· Omaha, NE

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