A Study of V118 Formulation C (V118C) in Healthy Participants (V118C-001)
Purpose
The goal of this study is to learn how safe V118 Formulation C is in Healthy Adults and how well people tolerate it.
Condition
- Healthy
Eligibility
- Eligible Ages
- Between 18 Years and 49 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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 Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental V118C |
Participants receive intramuscular (IM) injection of V118C in a 2-dose regimen administered on Day 1 and Day 29. |
|
|
Experimental V118 |
Participants receive IM injection of V118 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. |
|
Recruiting Locations
University of Texas Medical Branch ( Site 0001)
Galveston, Texas 77555-1115
Galveston, Texas 77555-1115
Contact:
Study Coordinator
409-772-5767
Study Coordinator
409-772-5767
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC