A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants

Inclusion criteria

• Healthy male or female infant ≥42 days to ≤89 days.
• Full-term infant at least 37 weeks gestational age at birth.
• Afebrile for ≥72 hours with an tympanic or rectal temperature <38.0°C (<100.4°F) before receipt of study vaccine.*Criterion applies to each vaccination. If not met, visit may be rescheduled for a time when no longer febrile for ≥72 hours.
• 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 tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
• Subject's parent/legal guardian has an email 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 of hepatitis B vaccine).
• Known hypersensitivity to any vaccine.
• Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
• Use of any immunosuppressive therapy or planned use through the last blood draw (Visit 6). Receipt of a <14-day course of systemic corticosteroids is not exclusionary if completed ≥1 month prior to first study vaccination. Topical and inhaled/nebulized steroids are also permitted.
• History of failure to thrive or prior hospitalization for any chronic condition.
• Subject has a bleeding disorder contraindicating IM vaccination.
• Subject or his/her mother has documented hepatitis B surface antigen-positive test.
• Subject has a known neurologic or cognitive behavioral disorder.
• Subject 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 plans to receive another investigational product 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.