RecruitingPhase 1NCT07168915

A Study of V118E in Healthy Participants (V118E-003)

A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation E in Healthy Adults


Sponsor

Merck Sharp & Dohme LLC

Enrollment

126 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Researchers are looking for new vaccines to prevent illnesses caused by a type of bacteria called Streptococcus pneumoniae. There are many different types of Streptococcus pneumoniae bacteria, called serotypes. Vaccines contain small parts of certain serotypes. These parts will not cause an infection but help the body create antibodies (proteins) to fight the bacteria. PREVNAR 20™ is a vaccine given to help to prevent disease from Streptococcus pneumoniae bacteria. Researchers designed a new vaccine, V118E, to help prevent disease from Streptococcus pneumoniae bacteria. The goal of this study is to learn how safe V118 formulation E is in Healthy Adults and how well people tolerate it.


Eligibility

Min Age: 18 YearsMax Age: 49 Years

Inclusion Criteria1

  • \- Is in good health before randomization

Exclusion Criteria2

  • Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination
  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases

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Interventions

BIOLOGICALV118E

IM administration

BIOLOGICALPREVNAR 20™

IM administration

BIOLOGICALSaline

IM administration


Locations(4)

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Hallandale, Florida, United States

QPS-MRA, LLC-Early Phase ( Site 0002)

South Miami, Florida, United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0004)

Springfield, Missouri, United States

University of Texas Medical Branch ( Site 0001)

Galveston, Texas, United States

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NCT07168915


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