Recruiting
Phase 1

V118E

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07168915

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

V118E

PREVNAR 20™

Saline

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT07168915

Start date

Oct 8, 2025

Status verified date

Jul, 2026

Completion date

Jul 6, 2027

Anticipated

Primary completion date

Jul 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Inclusion Criteria:

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

\- Is in good health before randomization

Exclusion Criteria:

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

  • 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 Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: V118E

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

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.

Interventions

V118E

IM administration

PREVNAR 20™

IM administration

Saline

IM administration

Primary outcome measure

  • Number of Participants With Solicited Injection-Site Adverse Events (AEs) [ Time Frame: 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 ]
  • Number of Participants With Immediate AEs Following Vaccination [ Time Frame: Up to approximately 30 minutes after each vaccination ]
  • Number of Participants With Unsolicited AEs [ Time Frame: 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 ]
  • Number of Participants With a Medically Attended Adverse Event (MAAE) [ Time Frame: Up to approximately 12 months after final vaccination ]
  • Number of Participants With an Adverse Events of Special Interest (AESI) [ Time Frame: Up to approximately 12 months after final vaccination ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Recruiting

Hallandale, Florida, United States, 33009

Contacts

Study Coordinator

954-455-5757

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

Recruiting

Springfield, Missouri, United States, 65802

Contacts

Study Coordinator

417-893-6113

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-07-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.