Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)

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

This study is designed to assess the safety, tolerability, and immunogenicity of 5 different formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1 and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of Period 2.

Inclusion Criteria

Infants:

- Healthy and able to attend all scheduled visits.

Adults:

- Highly unlikely to conceive from vaccination to 6 weeks after administration of the vaccine.

Exclusion Criteria

Infants and Adults:

• Prior administration of any pneumococcal vaccine, any non-live vaccine within 14 days, or any live vaccine within 30 days.
• History of invasive pneumococcal disease.
• Known hypersensitivity to any vaccine component.
• Received systemic corticosteroids within 14 days of first vaccination.
• Known or suspected impairment of immune function.
• Febrile illness within 72 hours before vaccination.
• Received blood transfusion or blood products within 30 days. Infants
• Mother has documented human immunodeficiency virus or is hepatitis B surface antigen positive.
• Has asplenia or failure to thrive.

Adults:

- Is breastfeeding.