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A Study of V118 Formulation C (V118C) in Healthy Participants (V118C-001)

NCT ID: NCT06611033

Last Updated: 2026-01-20

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-25

Study Completion Date

2026-01-09

Brief Summary

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The goal of this study is to learn how safe V118 Formulation C is in Healthy Adults and how well people tolerate it.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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V118C

Participants receive intramuscular (IM) injection of V118C in a 2-dose regimen administered on Day 1 and Day 29.

Group Type EXPERIMENTAL

V118C

Intervention Type BIOLOGICAL

Intramuscular Administration

V118

Participants receive IM injection of V118 in a 2-dose regimen administered on Day 1 and Day 29.

Group Type EXPERIMENTAL

V118

Intervention Type BIOLOGICAL

Intramuscular Administration

Saline

Intervention Type BIOLOGICAL

Intramuscular 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

Intramuscular Administration

Saline

Intervention Type BIOLOGICAL

Intramuscular Administration

Interventions

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V118C

Intramuscular Administration

Intervention Type BIOLOGICAL

V118

Intramuscular Administration

Intervention Type BIOLOGICAL

PREVNAR 20™

Intramuscular Administration

Intervention Type BIOLOGICAL

Saline

Intramuscular Administration

Intervention Type BIOLOGICAL

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, 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

Research Centers of America ( Hollywood ) ( Site 0002)

Hollywood, Florida, United States

Site Status

University of Texas Medical Branch ( Site 0001)

Galveston, Texas, United States

Site Status

Countries

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United States

Related Links

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https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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V118C-001

Identifier Type: -

Identifier Source: org_study_id

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