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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
0.5 mL, Intramuscular (Low dose)
0.5 mL, Intramuscular (Middle dose)
0.5 mL, Intramuscular (High dose)
Unnamed facility
Allschwil, Switzerland
Number and percentage of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time frame: Days 0 through 30 post-vaccination
Immunogenicity of Pneumococcal Vaccine After two Vaccinations
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Time frame: Days 0 and 30 days post-vaccination
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0.5 mL, Intramuscular