Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
NCT ID: NCT00444457
Last Updated: 2012-10-15
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
PHASE3
1712 participants
INTERVENTIONAL
2007-05-31
2009-06-30
Brief Summary
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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
DOUBLE
Study Groups
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1
13-valent Pneumococcal Conjugate Vaccine
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
2
13-valent Pneumococcal Conjugate Vaccine
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
3
13-valent Pneumococcal Conjugate Vaccine
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
4
7vPnC
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
Interventions
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13-valent Pneumococcal Conjugate Vaccine
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
7vPnC
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
Eligibility Criteria
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Inclusion Criteria
* Available for the duration of the study and reachable by telephone
* Able to complete two blood drawing procedures during the study
Exclusion Criteria
* Bleeding disorder, immune deficiency or significant chronic or congenital disease
* Previous receipt of blood products or immune globulin
42 Days
98 Days
ALL
Yes
Sponsors
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Wyeth is now a wholly owned subsidiary of 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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Benton, Arkansas, United States
Conway, Arkansas, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
North Little Rock, Arkansas, United States
Downey, California, United States
Fontana, California, United States
Fountain Valley, California, United States
Lakewood, California, United States
Loma Linda, California, United States
Moreno Valley, California, United States
Paramount, California, United States
Riverside, California, United States
Rolling Hills Estates, California, United States
Boulder, Colorado, United States
Longmont, Colorado, United States
Norwich, Connecticut, United States
Palm Beach Gardens, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
DeKalb, Illinois, United States
Bardstown, Kentucky, United States
Crestview Hills, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Fall River, Massachusetts, United States
Jamaica Plain, Massachusetts, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Whitehouse Station, New Jersey, United States
Fishkill, New York, United States
Hopewell Jct, New York, United States
Ithaca, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Cary, North Carolina, United States
Durham, North Carolina, United States
Durham, North Carolina, United States
Sylva, North Carolina, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Huber Heights, Ohio, United States
Kettering, Ohio, United States
Mason, Ohio, United States
Tulsa, Oklahoma, United States
Kittanning, Pennsylvania, United States
Latrobe, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Clarksville, Tennessee, United States
Franklin, Tennessee, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
Galveston, Texas, United States
San Antonio, Texas, United States
Layton, Utah, United States
Murray, Utah, United States
South Jordan, Utah, United States
Vienna, Virginia, United States
Vancouver, Washington, United States
Vancouver, Washington, United States
Vancouver, Washington, United States
La Crosse, Wisconsin, United States
Marshfield, Wisconsin, United States
Monroe, Wisconsin, United States
Countries
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References
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Payton T, Girgenti D, Frenck RW, Patterson S, Love J, Razmpour A, Sidhu MS, Emini EA, Gruber WC, Scott DA. Immunogenicity, safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States. Pediatr Infect Dis J. 2013 Aug;32(8):871-80. doi: 10.1097/INF.0b013e3182906499.
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.
Other Identifiers
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6096A1-3005
Identifier Type: -
Identifier Source: org_study_id