A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants

This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

Inclusion Criteria:

Adult Cohort: 18 to 49 years and in good health

• Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.

Infant Cohort: approximately 2 months (42 to 90 days) and in good health.

Exclusion Criteria:

Adult cohort: Prior administration of any pneumococcal vaccine

• History of invasive pneumococcal disease
• Known hypersensitivity to any vaccine component
• Known or suspected impairment of immune function
• Coagulation disorder contraindicating intramuscular vaccination
• Received a blood transfusion or blood products within 6 months
• Participated in another clinical study of an investigational product within 2 months
• Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
• Known hypersensitivity to any vaccine component
• Known or suspected impairment of immune function
• History of congenital or acquired immunodeficiency
• Has or mother has documented Human Immunodeficiency virus (HIV) infection
• Has or mother has documented hepatitis B surface antigen positive result
• Functional or anatomic asplenia
• History of failure to thrive
• Coagulation disorder contraindicating intramuscular vaccination
• History of autoimmune disease or autoimmune disorder
• Known neurologic or cognitive behavioral disorder
• Received systemic corticosteroids within 14 days
• Received other licensed non-live vaccine within 14 days
• Received other licensed live virus vaccine within 30 days
• Received a blood transfusion or blood products
• Participated in another clinical study of an investigational product
• History of invasive pneumococcal disease