The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)
NCT ID: NCT01513551
Last Updated: 2018-12-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
692 participants
INTERVENTIONAL
2012-03-13
2013-02-15
Brief Summary
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The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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V114
Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
Pneumococcal Conjugate Vaccine (V114)
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
PNEUMOVAX® 23
Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.
PNEUMOVAX® 23
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.
PREVNAR 13®
Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
PREVNAR 13®
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
Interventions
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Pneumococcal Conjugate Vaccine (V114)
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
PNEUMOVAX® 23
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.
PREVNAR 13®
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known or suspected to be immunocompromised
* Functional or anatomic asplenia
* History of autoimmune disease
* Evidence of dementia or cognitive impairment
* Use of any immunosuppressive therapy
* Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine
* Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine
* Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine
* Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine
* History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
* Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine
50 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
Countries
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References
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Ermlich SJ, Andrews CP, Folkerth S, Rupp R, Greenberg D, McFetridge RD, Hartzel J, Marchese RD, Stek JE, Abeygunawardana C, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults >/=50 years of age. Vaccine. 2018 Oct 29;36(45):6875-6882. doi: 10.1016/j.vaccine.2018.03.012. Epub 2018 Mar 17.
Other Identifiers
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2011-004542-18
Identifier Type: OTHER
Identifier Source: secondary_id
V114-002
Identifier Type: OTHER
Identifier Source: secondary_id
V114-002
Identifier Type: -
Identifier Source: org_study_id