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

January 16, 2026 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Hallandale, Florida, United States, 33009
        • Velocity Clinical Research, Hallandale Beach ( Site 0003)
      • Hollywood, Florida, United States, 33024
        • Research Centers of America ( Hollywood ) ( Site 0002)
    • Texas
      • Galveston, Texas, United States, 77555-1115
        • University of Texas Medical Branch ( Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

The main inclusion criteria include but are not limited to the following:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: V118C
Participants receive intramuscular (IM) injection of V118C in a 2-dose regimen administered on Day 1 and Day 29.
Biological: V118C
Intramuscular Administration
Experimental: V118
Participants receive IM injection of V118 in a 2-dose regimen administered on Day 1 and Day 29.
Biological: V118
Intramuscular Administration
Biological: Saline
Intramuscular Administration
Active Comparator: 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.
Biological: Saline
Intramuscular Administration
Biological: PREVNAR 20™
Intramuscular Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Solicited Injection Site Adverse Events (AEs)
Time Frame: Up to approximately 7 days after each vaccination
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited injection-site AE will be reported.
Up to approximately 7 days after each vaccination
Number of Participants with Solicited Systemic AEs
Time Frame: Up to approximately 7 days after each vaccination
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited systemic AE will be reported.
Up to approximately 7 days after each vaccination
Number of Participants with Immediate AEs Following Vaccination
Time Frame: Up to approximately 30 minutes after each vaccination
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with Immediate AEs following vaccination will be reported.
Up to approximately 30 minutes after each vaccination
Number of Participants with Unsolicited AEs
Time Frame: Up to approximately 28 days after each vaccination
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. An unsolicited AE is an AE that is not solicited using a vaccine report card (VRC) and that is communicated by a participant. The number of participants that experienced an unsolicited AE will be reported.
Up to approximately 28 days after each vaccination
Number of Participants With a Serious Adverse Event (SAE)
Time Frame: Up to approximately 12 months after final vaccination
An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The number of participants who experience an SAE will be reported.
Up to approximately 12 months after final vaccination
Number of Participants with a Medically Attended Adverse Event (MAAE)
Time Frame: Up to approximately 12 months after final vaccination
An MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. The number of participants who experience an MAAE will be reported.
Up to approximately 12 months after final vaccination
Number of Participants with an Event of Clinical Interest (ECI)
Time Frame: Up to approximately 12 months after final vaccination
An ECI includes but is not limited to: 1) An overdose defined as: A participant receiving more than 1 dose of study vaccine in a 24-hour period or more than 2 doses of study vaccine throughout the study. 2) Potential drug-induced liver injury (DILI) events defined as: An elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is ≥3 times the upper limit of normal (ULN) and an elevated total bilirubin lab value that is ≥2 times ULN and, at the same time, an alkaline phosphatase lab value that is <2 times ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. 3) Potential immune-mediated disease (pIMDs) defined as: A subset of AEs that include either an established autoimmune disease(s) or Inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The number of participants who experience an ECI will be reported.
Up to approximately 12 months after final vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs)
Time Frame: Day 28 postvaccination
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay.
Day 28 postvaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Actual)

January 9, 2026

Study Completion (Actual)

January 9, 2026

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V118C-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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