Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)
Streptococcus Pneumoniae Infection, Pneumococcal Infections
About this trial
This is an interventional prevention trial for Streptococcus Pneumoniae Infection
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Adult V114: 1x:1x:1x
Adult V114: 2x:2x:2x
Infant V114: 1x:1x:1x
Infant V114: 2x:1x:2x
Infant V114: 2x:2x:2x
Infant V114: 0.5x:0.5x:2x
Infant V114: 1x:1x:2x
Infant Prevnar 13®
Adults receive a single vaccination on Day 1.
Adults receive a single vaccination on Day 1.
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.