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

Part of paid clinical trials in Hallandale, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07168915
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • V118E — BIOLOGICAL
    IM administration
  • PREVNAR 20™ — BIOLOGICAL
    IM administration
  • Saline — BIOLOGICAL
    IM administration

Study Details

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.

Key Dates

Start date
Oct 8, 2025
Status verified
Feb 2026
Primary completion
Nov 12, 2027
Completion
Nov 12, 2027

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Number of Participants With Solicited Injection-Site Adverse Events (AEs) [ Time Frame: Up to approximately 7 days after each vaccination ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Velocity Clinical Research, Hallandale Beach ( Site 0003)HallandaleFlorida33009
Study Coordinator
954-455-5757
QPS-MRA, LLC-Early Phase ( Site 0002)South MiamiFlorida33143
Study Coordinator
305-722-0970
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0004)SpringfieldMissouri65802
Study Coordinator
417-893-6113
University of Texas Medical Branch ( Site 0001)GalvestonTexas77555-1115
Study Coordinator
409-772-5278

Find similar trials in Hallandale, FL

By research site
Velocity Clinical Research, Hallandale Beach· Hallandale, FLQPS-MRA, LLC-Early Phase· South Miami, FLBio-Kinetic Clinical Applications, LLC dba QPS-MO· Springfield, MOUniversity of Texas Medical Branch· Galveston, TX

Related Studies