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

Eligibility Criteria

• 1. Healthy male or female infant ≥42 days to ≤89 days.
• 2. Full-term infant at least 37 weeks gestational age at birth.
• 3. 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.
• 4. Able to attend all scheduled visits and comply with the study procedures.
• 5. Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
• 6. 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.
• 7. Subject's parent/legal guardian has an email address and access to a computer or smartphone with internet to complete the eDiary.
• 1. 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.
• 2. Previous receipt of a licensed or investigational vaccine (excluding 1 dose of hepatitis B vaccine).
• 3. Known hypersensitivity to any vaccine.
• 4. Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
• 5. 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.
• 6. History of failure to thrive or prior hospitalization for any chronic condition.
• 7. Subject has a bleeding disorder contraindicating IM vaccination.
• 8. Subject or his/her mother has documented hepatitis B surface antigen-positive test.
• 9. Subject has a known neurologic or cognitive behavioral disorder.
• 10. Subject has a known clinically significant congenital malformation or serious chronic disorder.
• 11. Receipt of a blood transfusion or blood products, including immunoglobulins.
• 12. 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.
• 13. Any infant who cannot be adequately followed for safety according to the protocol plan.
• 14. Any other reason that in the opinion of the Investigator may interfere with the evaluation required by the study.