A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001).

Part of paid clinical trials in Glendale, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06655324
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
12 Years - 30 Years
Healthy Volunteers
Accepted

Interventions

  • V350A — BIOLOGICAL
    Vaccination administered via intramuscular injection
  • V350B — BIOLOGICAL
    Vaccination administered via intramuscular injection
  • Placebo — BIOLOGICAL
    Vaccination administered via intramuscular injection

Study Details

Epstein Barr virus (EBV) is a virus which can cause infectious mononucleosis and is associated with certain kinds of cancer and multiple sclerosis. Researchers are looking for new ways to prevent disease related to EBV and have developed a new study vaccine (V350A and V350B). The main goal of this study is to learn about the safety and tolerability of V350A and V350B in healthy adults.

Key Dates

Start date
Dec 5, 2024
Status verified
May 2026
Primary completion
Jul 17, 2028
Completion
Jul 17, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: V350A
    Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6.
  • Experimental: V350B
    Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6.
  • Placebo Comparator: Placebo
    Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6.

Primary Outcome Measure

Number of Participants with Solicited Injection Site Adverse Events (AEs) [ Time Frame: Up to approximately 6 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
California Clinical Trials Medical Group managed by PAREXEL ( Site 0011)GlendaleCalifornia91206-
QPS-MRA, LLC ( Site 0012)South MiamiFlorida33143-
Alliance for Multispecialty Research, LLC ( Site 0008)Kansas CityMissouri64114
Study Coordinator
816-943-0770
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016)SpringfieldMissouri65802
Study Coordinator
417-831-2048
Velocity Clinical Research Lincoln ( Site 0004)LincolnNebraska68510
Study Coordinator
308-365-8900
Velocity Clinical Research, Omaha ( Site 0005)OmahaNebraska68134-
Remington-Davis, Inc. ( Site 0017)ColumbusOhio43215
Study Coordinator
614-487-2560
Lynn Health Science Institute ( Site 0010)Oklahoma CityOklahoma73112
Study Coordinator
405-602-3939
Alliance for Multispecialty Research, LLC ( Site 0009)KnoxvilleTennessee37909-

Find similar trials in Glendale, CA

By research site
California Clinical Trials Medical Group managed by PAREXEL· Glendale, CAQPS-MRA, LLC· South Miami, FLAlliance for Multispecialty Research, LLC· Kansas City, MOBio-Kinetic Clinical Applications, LLC dba QPS-MO· Springfield, MOVelocity Clinical Research Lincoln· Lincoln, NEVelocity Clinical Research, Omaha· Omaha, NE

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