Recruiting

Safety and Immunogenicity of V118E Vaccine in Healthy Adults

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

V118E

+ PREVNAR 20™

+ Saline

Biological
Who is being recruted

From 18 to 49 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 1
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: October 8, 2025

Actual date on which the first participant was enrolled.

Researchers are conducting a study to test a new vaccine, called V118E, which may help prevent illnesses caused by the bacteria Streptococcus pneumoniae. This bacteria has many different types known as serotypes. Vaccines usually include small parts of these serotypes to train the immune system to fight off infections without causing illness. The study aims to see how safe this new vaccine is and how well healthy adults can tolerate it. This research is important because it could lead to better protection against diseases caused by this bacteria, which can lead to serious health issues. In this study, healthy adult participants will receive the V118E vaccine to evaluate its safety and how well it is tolerated. The vaccine is likely administered through an injection. Researchers will monitor the participants for any side effects or reactions to the vaccine to ensure it is safe. The study does not detail specific risks or benefits but focuses on the safety and immune response to the vaccine. By understanding these factors, researchers hope to develop a vaccine that can effectively prevent illnesses caused by Streptococcus pneumoniae.

Official TitleA Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation E in Healthy Adults 
NCT07168915
Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

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

126 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 49 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
Is in good health before randomization

2 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Hallandale, United StatesSee the location
Recruiting

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

South Miami, United States
Recruiting

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

Springfield, United States
Recruiting

University of Texas Medical Branch ( Site 0001)

Galveston, United States
Recruiting
4 Study Centers