The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels.
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Incidence of immediate reactogenicity adverse events
Timeframe: Up to 30 minutes after each dose
Incidence of solicited reactogenicity events
Timeframe: Up to 7 days after each dose
Incidence of adverse events (AEs)
Timeframe: Up to study day 61
Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI)
Timeframe: Up to study day 224
Changes in safety laboratory results compared to baseline
Timeframe: Up to study day 61
Changes in vital signs compared to baseline
Timeframe: Up to study day 61
Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA)
Timeframe: Up to study day 224