The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
752
0.5 mL of VAX-31 will be administered into the deltoid muscle
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
Serotype-specific OPA geometric mean titers (GMT)
Time frame: 1 month after VAX-31 vaccination
Serotype-specific OPA geometric mean fold rise (GMFR) from baseline
Time frame: 1 month after VAX-31 vaccination
Percentage of subjects reporting solicited local adverse events (AE) (redness, swelling, and pain at injection site)
Time frame: up to 7 days after vaccination
Percentage of subjects reporting solicited systemic AE (fever, headache, fatigue, muscle pain, and joint pain)
Time frame: up to 7 days after vaccination
Percentage of subjects reporting unsolicited AE
Time frame: up to 31 days after vaccination
Percentage of subjects reporting new onset of chronic illness (NOCI), medically attended AE (MAAE), and serious adverse events (SAE)
Time frame: up to 6 months after vaccination
Serotype-specific IgG geometric mean concentration (GMC)
Time frame: 1 month after VAX-31 vaccination
Serotype-specific IgG geometric mean fold-rise (GMFR) from baseline
Time frame: 1 month after VAX-31 vaccination
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