Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants

Exclusion Criteria

• •1. Congenital abnormality or serious chronic disorder requiring treatment or likely to affect normal growth or development
• •2. Any condition that may increase risk of study participation or interfere with interpretation of study results
• •3. Immunodeficiency or chronic administration (\> 14 consecutive days) of immunosuppressant or other immune-modifying drugs (see details in Section 6.6.2), including systemic glucocorticoids, within 6 months before Day 1 (topical, intra- articular, or inhaled glucocorticoids permitted)
• •4. History of sepsis or pneumonia
• •5. History of anaphylaxis or angioedema
• •6. History of severe reaction to immunization
• •7. Known hypersensitivity to any of the ingredients in either IVT PCV-25 or Prevnar 20
• •8. Contraindication to any concomitant vaccine or to Prevnar 20, according to each vaccine's product information
• •9. Prior receipt of a licensed or investigational pneumococcal vaccine
• •10. Prior receipt of any diphtheria, tetanus, pertussis, Hib, or polio vaccine
• •11. Prior receipt of \> 1 dose of HepB vaccine
• •12. Receipt of HepB vaccine at age ≥ 30 days
• •13. Receipt of an inactivated vaccine within 14 days before Day 1 or planned receipt through Day 85 other than as described in Section 6.6.1 and Section 6.6.3
• •14. Receipt of a live vaccine within 28 days before Day 1 or planned receipt through Day 85 other than as described in Section 6.6.1 and Section 6.6.3
• •15. Receipt of blood transfusion or blood products before Day 1 or planned receipt through Day 85
• •16. Receipt of any other IP before Day 1
• •17. Planned elective hospitalization or surgical procedure through the end of the study
• •18. Family member of employee of Inventprise, vendors, or research sites associated with the study
• •19. Any medical, psychiatric, or social condition, or occupational or other responsibility of the parent/guardian that, in the judgment of the Investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or an ability to provide informed consent
• •Temporary Delay Criteria: administration of IVT PCV-25 / Prevnar20 will be delayed for any participant who meets any of the following criteria:
• •1. Receipt of any inactivated vaccine within 14 days or any live vaccine within 28 days
• •2. Febrile illness (eg, temperature ≥ 38.0°C) or other acute illness within 48 hours
• •3. Any other signs or symptoms or medication use that could inhibit the proper vaccine administration of the IP or interpretation of diary data