This study is designed to evaluate the safety, tolerability, and immunogenicity of two investigational pneumococcal vaccines at three dose levels in healthy adults. Primary Objective: \- To evaluate the safety and tolerability of two investigational pneumococcal vaccines. Observational Objective: \- To evaluate the immunogenicity of the investigational pneumococcal vaccines.
An initial cohort of 6 participants will receive a single dose of one of two investigational pneumococcal vaccines. After safety evaluation of that cohort, additional cohorts will receive 2 injections 30 days apart of same investigational pneumococcal vaccine at same or increased 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
131
0.5 mL, intramuscular (1 middle dose)
0.5 mL, intramuscular (2 low doses)
0.5 mL, intramuscular (2 middle doses)
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: 30 days post-vaccination
Immunogenicity of Investigational Pneumococcal vaccines after 2 vaccinations
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA).
Time frame: Days 0 and 30 post-vaccination
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0.5 mL, intramuscular (2 middle doses)
0.5 mL, intramuscular (2 high doses)
0.5 mL, intramuscular