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

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