The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years of age to adults 18-49 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4,000
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
0.5 mL of the 21 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
Serotype-specific OPA geometric mean titers (GMT) in 50 year olds and above
Time frame: 1 month after 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 serious adverse events (SAE), new onset of chronic illness (NOCI), and medically attended adverse events (MAAE)
Time frame: up to 6 Months after vaccination
Serotype-specific OPA geometric mean titers (GMT) in 18 to 49 year olds and 50 to 64 year olds
Time frame: 1 month after vaccination
Serotype-specific IgG geometric mean concentrations (GMC) in 50 year olds and above
Time frame: 1 month after vaccination
Serotype-specific IgG GMC in 18 to 49 year olds and 50 to 64 year olds
Time frame: 1 month after vaccination
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