Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
NCT ID: NCT00546572
Last Updated: 2011-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
938 participants
INTERVENTIONAL
2007-11-30
2010-07-31
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
DOUBLE
Study Groups
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1
Receives 13vPnC at year 0 and 13vPnC at year 1
13 valent Pneumococcal Conjugate Vaccine
0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
2
Receives 23vPS at year 0 and 13vPnC at year 1
23vPS
0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
Interventions
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13 valent Pneumococcal Conjugate Vaccine
0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
23vPS
0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
Eligibility Criteria
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Inclusion Criteria
* Documented vaccination with 1 dose of 23vPS at least 5 years previous.
* Healthy.
Exclusion Criteria
* History of severe adverse reaction to a vaccine.
* Immunodeficiency.
70 Years
ALL
Yes
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Fountain Valley, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Waterbury, Connecticut, United States
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Coral Gables, Florida, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Pinellas Park, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Stockbridge, Georgia, United States
Pfizer Investigational Site
Shawnee Mission, Kansas, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Butte, Montana, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Cary, North Carolina, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Hickory, North Carolina, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Salisbury, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Fargo, North Dakota, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Corvallis, Oregon, United States
Pfizer Investigational Site
Eugene, Oregon, United States
Pfizer Investigational Site
Carnegie, Pennsylvania, United States
Pfizer Investigational Site
Downington, Pennsylvania, United States
Pfizer Investigational Site
Grove City, Pennsylvania, United States
Pfizer Investigational Site
Penndel, Pennsylvania, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Upper Saint Clair, Pennsylvania, United States
Pfizer Investigational Site
Greer, South Carolina, United States
Pfizer Investigational Site
Mt. Pleasant, South Carolina, United States
Pfizer Investigational Site
Bristol, Tennessee, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Arlöv, , Sweden
Pfizer Investigational Site
Boden, , Sweden
Pfizer Investigational Site
Degeberga, , Sweden
Pfizer Investigational Site
Gothenburg, , Sweden
Pfizer Investigational Site
Malmo, , Sweden
Pfizer Investigational Site
Umeå, , Sweden
Pfizer Investigational Site
Uppsala, , Sweden
Countries
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Related Links
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Other Identifiers
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B1851024
Identifier Type: -
Identifier Source: secondary_id
6115A1-3005
Identifier Type: -
Identifier Source: org_study_id
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