Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants

Inclusion criteria

• Healthy male or female infant ≥42 days to ≤89 days (inclusive).
• Full-term infant at least 37 weeks gestational age at birth.
• Afebrile for ≥72 hours with a rectal temperature <38.0°C (<100.4°F) or axillary temperature <37.8°C (<100.0°F) before receipt of study vaccine.*
• Able to attend all scheduled visits and comply with the study procedures.
• Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
• Subject's parent/legal guardian is able to fill out an ediary of solicited AE and take daily axillary temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
• Subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary.

Exclusion criteria

• History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
• Previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis B vaccine).
• Known hypersensitivity to any vaccine.
• Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency).
• Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted).
• History of failure to thrive.
• Subject has a coagulation disorder contraindicating IM vaccination.
• Subject or his/her mother have documented hepatitis B surface antigen-positive.
• Has a known neurologic or cognitive behavioral disorder.
• Has a known clinically significant congenital malformation or serious chronic disorder.
• Receipt of a blood transfusion or blood products, including immunoglobulins.
• Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
• Any infant who cannot be adequately followed for safety according to the protocol plan.
• Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.