V118E vaccine in healthy adults
A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation E in Healthy Adults
PHASE1 · Merck Sharp & Dohme LLC · NCT07168915
This trial will test whether the new V118E vaccine is safe and well tolerated in healthy adults.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC (industry) |
| Locations | 4 sites (Hallandale, Florida and 3 other locations) |
| Trial ID | NCT07168915 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1 interventional study in healthy adult volunteers comparing the investigational V118E vaccine with PREVNAR 20™ and saline. Participants receive study injections and are monitored for side effects, vital signs, and laboratory abnormalities to characterize safety and tolerability. Blood samples may be taken to look for antibody responses to pneumococcal serotypes. Follow-up visits occur at the listed clinical sites to capture short-term and any longer-term reactions.
Who should consider this trial
Good fit: Healthy adults in good general health without recent invasive pneumococcal disease or major underlying medical conditions are the intended participants.
Not a fit: People with recent invasive pneumococcal disease or with significant endocrine, cardiovascular, neurological, immunological, hepatic, renal, hematological, respiratory, gastrointestinal, or genitourinary disorders would be excluded and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, V118E could provide an additional vaccine option to help prevent disease caused by multiple Streptococcus pneumoniae serotypes.
How similar studies have performed: Licensed pneumococcal conjugate vaccines such as PREVNAR 20™ have demonstrated effectiveness, but V118E is a new formulation being tested primarily for safety.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hallandale, Florida and 3 other locations
- Velocity Clinical Research, Hallandale Beach ( Site 0003) — Hallandale, Florida, United States (RECRUITING)
- QPS-MRA, LLC-Early Phase ( Site 0002) — South Miami, Florida, United States (RECRUITING)
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0004) — Springfield, Missouri, United States (RECRUITING)
- University of Texas Medical Branch ( Site 0001) — Galveston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy