Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)
Status and phase
Completed
Phase 2
Phase 1
Conditions
Streptococcus Pneumoniae Infection
Pneumococcal Infections
Treatments
Biological: Prevnar 13®
Biological: V114 2x:1x:2x
Biological: V114 1x:1x:1x
Biological: V114 2x:2x:2x
Biological: V114 1x:1x:2x
Biological: V114 0.5x:0.5x:2x
Details and patient eligibility
About
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.
Enrollment
341 patients
Sex
All
Ages
6 weeks to 49 years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion 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.
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
341 participants in 8 patient groups
Adult V114: 1x:1x:1x
Experimental group
Description:
Adults receive a single vaccination on Day 1.
Treatment:
Biological: V114 1x:1x:1x
Adult V114: 2x:2x:2x
Experimental group
Description:
Adults receive a single vaccination on Day 1.
Treatment:
Biological: V114 2x:2x:2x
Infant V114: 1x:1x:1x
Experimental group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 1x:1x:1x
Infant V114: 2x:1x:2x
Experimental group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 2x:1x:2x
Infant V114: 2x:2x:2x
Experimental group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 2x:2x:2x
Infant V114: 0.5x:0.5x:2x
Experimental group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 0.5x:0.5x:2x
Infant V114: 1x:1x:2x
Experimental group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 1x:1x:2x
Infant Prevnar 13®
Active Comparator group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: Prevnar 13®
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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