A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)
Status and phase
Completed
Phase 2
Phase 1
Conditions
Pneumococcal Infections
Treatments
Biological: V114 Medium Dose with Alternative Carrier Protein
Biological: Prevnar 13™
Biological: V114 Medium Dose
Biological: V114 High Dose
Biological: V114 High Dose with Alternative Carrier Protein
Details and patient eligibility
About
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.
Enrollment
338 patients
Sex
All
Ages
2 months to 49 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
338 participants in 9 patient groups
Adult: V114 Medium Dose
Experimental group
Description:
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.
Treatment:
Biological: V114 Medium Dose
Adult: V114 High Dose
Experimental group
Description:
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.
Treatment:
Biological: V114 High Dose
Adult: V114 Medium Dose with Alternative Carrier Protein
Experimental group
Description:
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.
Treatment:
Biological: V114 Medium Dose with Alternative Carrier Protein
Adult: V114 High Dose with Alternative Carrier Protein
Experimental group
Description:
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.
Treatment:
Biological: V114 High Dose with Alternative Carrier Protein
Infant: V114 Medium Dose
Experimental group
Description:
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 Medium Dose
Infant: V114 High Dose
Experimental group
Description:
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 High Dose
Infant: V114 Medium Dose with Alternative Carrier Protein
Experimental group
Description:
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 Medium Dose with Alternative Carrier Protein
Infant: V114 High Dose with Alternative Carrier Protein
Experimental group
Description:
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 High Dose with Alternative Carrier Protein
Infant: Prevnar 13™
Active Comparator group
Description:
Infant participants will receive a 0.5 mL intramuscular injection of Prevnar 13™ 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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