Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)
NCT ID: NCT02037984
Last Updated: 2019-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
341 participants
INTERVENTIONAL
2014-01-28
2016-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Adult V114: 1x:1x:1x
Adults receive a single vaccination on Day 1.
V114 1x:1x:1x
V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA).
Adult V114: 2x:2x:2x
Adults receive a single vaccination on Day 1.
V114 2x:2x:2x
V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
Infant V114: 1x:1x:1x
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
V114 1x:1x:1x
V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA).
Infant V114: 2x:1x:2x
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
V114 2x:1x:2x
V114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
Infant V114: 2x:2x:2x
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
V114 2x:2x:2x
V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
V114 0.5x:0.5x:2x
V114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
Infant V114: 1x:1x:2x
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
V114 1x:1x:2x
V114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
Infant Prevnar 13®
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Prevnar 13®
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 µg each), and 6B (4.4 µg) in each 0.5 mL dose.
Interventions
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Prevnar 13®
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 µg each), and 6B (4.4 µg) in each 0.5 mL dose.
V114 1x:1x:1x
V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA).
V114 2x:2x:2x
V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
V114 2x:1x:2x
V114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
V114 1x:1x:2x
V114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
V114 0.5x:0.5x:2x
V114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
Eligibility Criteria
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Inclusion Criteria
\- 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
* 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.
6 Weeks
49 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Rupp R, Hurley D, Grayson S, Li J, Nolan K, McFetridge RD, Hartzel J, Abeygunawardana C, Winters M, Pujar H, Benner P, Musey L. A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Hum Vaccin Immunother. 2019;15(3):549-559. doi: 10.1080/21645515.2019.1568159. Epub 2019 Feb 15.
Other Identifiers
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V114-004
Identifier Type: -
Identifier Source: org_study_id
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