A Study of V132 in Healthy Older Participants (V132-001)
Purpose
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
Condition
- Healthy
Eligibility
- Eligible Ages
- Between 50 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
The key inclusion criteria include but are not limited to the following: - Is in good health - Has body mass index (BMI) within 18.0 to 35.0 kg/m^2 (inclusive)
Exclusion Criteria
The key 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 received a pneumococcal polysaccharide vaccine in the previous 10 years, has received any pneumococcal conjugate vaccine at any time prior to this study
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1: Dose Escalation |
Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels. |
|
|
Experimental Part 2: Dose Expansion |
Participants will receive single IM doses of a V132 formulation or comparator regimen. Doses will be determined based on review of Part 1 data and will not exceed maximum dose level assessed in Part 1. |
|
Recruiting Locations
University of Texas Medical Branch ( Site 0004)
League City, Texas 77573
League City, Texas 77573
Contact:
Study Coordinator
832-340-2313
Study Coordinator
832-340-2313
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC