Pneumococcal Infections Clinical Trial
This study is designed to evaluate the safety, tolerability, and immunogenicity of an
investigational pneumococcal vaccine in healthy adult volunteers.
Primary Objective:
- To evaluate the safety and tolerability of an investigational pneumococcal vaccine.
Observational Objective:
- To evaluate the immunogenicity of an investigational Pneumococcal vaccine.
An initial cohort of 10 participants will receive a single dose of investigational pneumococcal vaccine. After safety assessment of this cohort during a 24-hour in-unit observation period, additional cohorts will receive two injections of the study vaccine 30 days apart, at three dose levels, in ascending doses by cohort, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each vaccination. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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