A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age

Exclusion Criteria

• •1. History of IPD or pneumococcal pneumonia (either confirmed or self-reported) at any age.
• •2. Previous receipt of a licensed or investigational pneumococcal vaccine at any age.
• •3. Previous receipt of an influenza vaccine from the current season; receipt of any influenza vaccine (licensed or investigational) within 6 months prior to Day 1; or receipt/planned receipt of any licensed or investigational non-study influenza vaccine during study participation.
• •4. Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
• •5. Planned or actual administration of any licensed vaccine within 30 days prior to Day 1.
• •6. Body temperature \>38.0°C (\>100.4°F) or acute illness within 3 days prior to study vaccination (participant may be rescreened).
• •7. Current diagnosis of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
• •8. History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination.
• •9. History of Guillain-Barré syndrome.
• •10. Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation.
• •11. Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency.
• •12. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
• •13. Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to Day 1.
• •14. Receiving immunosuppressive therapy.
• •15. Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent \>10 mg/day) within 14 days of study vaccinations. Note: Receipt of a ≥14-day course of systemic corticosteroids equivalent to ≤10 mg/day is permitted, as are inhaled, nebulized, topical, intra-articular, and intrabursal corticosteroids.
• •16. History of malignancy ≤5 years before to Day 1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
• •17. Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
• •18. Employee of, or first-degree relative of any person employed by the Sponsor, the contract research organization (CRO), the Investigator, study site personnel, or site.