drugset / Trial / NCT07059182
Safety Study of a Single Dose of Pneumococcal Whole-Cell Vaccine in Healthy Adults
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The goal of this clinical trial is to learn if whole-cell Streptococcus pneumoniae (wSp) vaccination is safe and tolerated in healthy adults. The main aim is to evaluate the safety and tolerability of wSp vaccine. Researchers will compare wSp vaccinated participants with placebo-treated participants. Participants will be administered once with 1mg wSp vaccine or placebo. After dosing, they will be followed up for 30 days. In addition to the screening and enrollment visits, each participant will come to the study site for scheduled study visits on Days 14 and 30 to undergo study evaluations and measurements and to monitor safety. Each participant also will receive scheduled phone calls on Days 3 and 7 to monitor safety.
Timeline
- Start
- 2025-06-11
- Primary completion
- 2025-08-29
- Completion
- 2025-08-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PATH-wSP | Vaccine | 1 mg | Intramuscular |