This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers. Primary Objective: * To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.
Each volunteer participant will receive two injections with one of three vaccine doses, administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each injection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
63
0.5 mL, intramuscular
0.5 mL, intramuscular
0.5 mL, intramuscular
Unnamed facility
Allschwil, Switzerland
The occurrence of 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: Day 0 up to Day 60 post vaccination
Immunogenicity of pneumococcal vaccine after 2 vaccinations
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA).
Time frame: Day 0 and 30 days post vaccination
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