Safety and Efficacy of wSp Vaccine in Young Children

Inclusion criteria

• Male or female who is 6 months (- 30 to +75 days) of age at time of enrollment
• Healthy subject as established by medical history and clinical examination before entering into the study.
• Received 3 doses of PCV15 or PCV20.
• Written informed consent obtained from the subject's parent/legal guardian.
• Parent/legal guardian able and willing to bring subject to all study visits.

Exclusion criteria

• Has a history of invasive pneumococcal disease (positive blood culture and/or positive cerebrospinal fluid culture).
• Known or suspected impairment of immunological function, based on medical history and physical examination.
• Has a history of congenital or acquired immunodeficiency.
• Chronic administration (defined > 14 consecutive days) of immunosuppressants or other immune-modifying drugs.
• Prior receipt since birth of immunoglobulins and/or any blood products or planned administration during the study period.
• Expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.
• External auditory canal atresia/stenosis.
• Has known or history of functional or anatomic asplenia.
• Has a bleeding disorder in which intramuscular vaccination would be contraindicated.
• 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.
• Direct descendant (child or grandchild) of study site personnel.

Temporary exclusion criteria

For day of vaccination:

• Fever (transcutaneous temperature ≥38.0°C) or acute illness, at investigator's discretion
• 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.