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NCT06655324PHASE1RecruitingAccepts Healthy Volunteers

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

Merck Sharp & Dohme LLC

Start Date

12/5/2024

Completion Date

7/17/2028

Summary

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.

Eligibility Criteria

Age Range: 12 years to 30 years

Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health before randomization. * Has a body mass index between 18 and 38 kg/m\^2, inclusive, for adults 18-30; has a body mass index between 15 and 38 kg/m\^2, inclusive, for adolescents 12-17. Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a confirmed or suspected case of infectious mononucleosis within 12 months prior to enrollment. * Has any immunosuppressive medical condition or receive any immunosuppressive therapy.

Interventions

BIOLOGICAL

V350A

BIOLOGICAL

V350B

BIOLOGICAL

Placebo

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Conditions

Healthy

Locations

California Clinical Trials Medical Group managed by PAREXEL ( Site 0011)

Glendale, California 91206

United States

QPS-MRA, LLC ( Site 0012)

South Miami, Florida 33143

United States

Alliance for Multispecialty Research, LLC ( Site 0008)

Kansas City, Missouri 64114

United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016)

Springfield, Missouri 65802

United States

Velocity Clinical Research Lincoln ( Site 0004)

Lincoln, Nebraska 68510

United States

Velocity Clinical Research, Omaha ( Site 0005)

Omaha, Nebraska 68134

United States

Remington-Davis, Inc. ( Site 0017)

Columbus, Ohio 43215

United States

Lynn Health Science Institute ( Site 0010)

Oklahoma City, Oklahoma 73112

United States

Alliance for Multispecialty Research, LLC ( Site 0009)

Knoxville, Tennessee 37909

United States