Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
NCT ID: NCT00373958
Last Updated: 2013-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
666 participants
INTERVENTIONAL
2006-09-30
2008-06-30
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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13vPnC vaccine
13 valent pneumococcal conjugate vaccine
1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
7vPnC vaccine
7vPnc pneumococcal conjugate vaccine
1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
Interventions
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13 valent pneumococcal conjugate vaccine
1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
7vPnc pneumococcal conjugate vaccine
1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
Eligibility Criteria
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Inclusion Criteria
* Available for the entire study period.
Exclusion Criteria
* Known contraindication to vaccination.
42 Days
98 Days
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Downey, California, United States
Fontana, California, United States
Loma Linda, California, United States
Paramount, California, United States
Riverside, California, United States
Centennial, Colorado, United States
Norwich, Connecticut, United States
Tampa, Florida, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Overland Park, Kansas, United States
Bardstown, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Rochester, New York, United States
The Bronx, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Mason, Ohio, United States
Latrobe, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Wexford, Pennsylvania, United States
Charleston, South Carolina, United States
Jackson, Tennessee, United States
The Woodlands, Texas, United States
Murray, Utah, United States
Provo, Utah, United States
Richmond, Virginia, United States
Vienna, Virginia, United States
Countries
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References
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Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.
Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, Jansen KU, Love J, Gruber WC, Emini EA, Scott DA; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010 Sep;126(3):e493-505. doi: 10.1542/peds.2009-3027. Epub 2010 Aug 23.
Other Identifiers
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6096A1-004
Identifier Type: -
Identifier Source: org_study_id
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