Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults



Status:Archived
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Compared to a 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) in Adults 60 to 64 Years Old Who Are Naive to 23vPS and the Safety, Tolerability, and Immunogenicity of 13vPnC in Adults 18 to 59 Years Old Who Are Naïve to 23vPS


This study will assess the safety, tolerability and immune response of 13-valent
pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide
Vaccine (23vPS). Although the study started with only 1 population, amendments to the
original protocol will now reflect three participant populations. Three age cohorts will be
enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3
(age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4
years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be
naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.



We found this trial at
16
sites
Pfizer Investigational Site
Boise, Idaho 83702
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Pfizer Investigational Site
Akron, Ohio 44314
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Pfizer Investigational Site
Alabaster, Alabama 35007
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Alabaster, AL
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Pfizer Investigational Site
Arkansas City, Kansas 67005
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Arkansas City, KS
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Pfizer Investigational Site
Asheville, North Carolina 28801
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Pfizer Investigational Site
Ashland, Kentucky 41101
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Ashland, KY
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Pfizer Investigational Site
Avon, Indiana 46123
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Avon, IN
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Raleigh Regional Cancer Center
Beckley, West Virginia 25801
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Beckley, WV
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Pfizer Investigational Site
Bristol, Tennessee 37620
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Bristol, TN
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Fletcher Allen Health Care
111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Burlington, VT
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Pfizer Investigational Site
Cape Girardeau, Missouri 63703
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Cape Girardeau, MO
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Pfizer Investigational Site
Cranston, Rhode Island 02920
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Cranston, RI
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Strong Memorial Hospital (University of Rochester School of Medicine)
601 Elmwood Ave
Rochester, New York 14642
(585) 275-2100
Strong Memorial Hospital (University of Rochester School of Medicine) In addition to offering traditional and...
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Rochester, NY
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Pfizer Investigational Site
Seattle, Washington 98166
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Seattle, WA
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Pfizer Investigational Site
West Jordan, Utah 84088
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West Jordan, UT
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