Safety and Efficacy of wSp Vaccine in Young Children

Exclusion Criteria

• •1. Has a history of invasive pneumococcal disease (positive blood culture and/or positive cerebrospinal fluid culture).
• •2. Known or suspected impairment of immunological function, based on medical history and physical examination.
• •3. Has a history of congenital or acquired immunodeficiency.
• •4. Chronic administration (defined \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs.
• •5. Prior receipt since birth of immunoglobulins and/or any blood products or planned administration during the study period.
• •6. Expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.
• •7. External auditory canal atresia/stenosis.
• •8. Has known or history of functional or anatomic asplenia.
• •9. Has a bleeding disorder in which intramuscular vaccination would be contraindicated.
• •10. Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in observational studies is permitted.
• •11. Direct descendant (child or grandchild) of study site personnel.
• •For day of vaccination:
• •12. Fever (transcutaneous temperature ≥38.0°C) or acute illness, at investigator's discretion
• •13. Has received systemic corticosteroids (equivalent of prednisone \> 0.5 mg/kg/day or equivalent) and not completed this course of treatment at least 30 days prior to the study vaccination. Inhaled, topical, and ophthalmic steroids are allowed.