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

NCT ID: NCT07168915

Last Updated: 2026-02-11

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2027-05-10

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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V118E

Participants receive intramuscular (IM) injection of V118E in a 2-dose regimen administered on Day 1 and Day 29.

Group Type EXPERIMENTAL

V118E

Intervention Type BIOLOGICAL

IM administration

PREVNAR 20™ + Saline

Participants receive one dose of IM injection of PREVNAR 20™ in a 2-dose regimen on Day 1 followed by one dose of saline on Day 29.

Group Type ACTIVE_COMPARATOR

PREVNAR 20™

Intervention Type BIOLOGICAL

IM administration

Saline

Intervention Type BIOLOGICAL

IM administration

Interventions

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V118E

IM administration

Intervention Type BIOLOGICAL

PREVNAR 20™

IM administration

Intervention Type BIOLOGICAL

Saline

IM administration

Intervention Type BIOLOGICAL

Other Intervention Names

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V118/VA-017

Eligibility Criteria

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Inclusion Criteria

\- Is in good health before randomization

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Velocity Clinical Research, Hallandale Beach ( Site 0003)

Hallandale, Florida, United States

Site Status RECRUITING

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

South Miami, Florida, United States

Site Status RECRUITING

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

Springfield, Missouri, United States

Site Status RECRUITING

University of Texas Medical Branch ( Site 0001)

Galveston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Toll Free Number

Role: CONTACT

1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

954-455-5757

Study Coordinator

Role: primary

305-722-0970

Study Coordinator

Role: primary

417-893-6113

Study Coordinator

Role: primary

409-772-5278

Related Links

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https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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V118E-003

Identifier Type: -

Identifier Source: org_study_id

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