Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
NCT ID: NCT00761631
Last Updated: 2013-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1200 participants
INTERVENTIONAL
2008-12-31
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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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Single
Open label
13 valent pneumococcal conjugate vaccine
Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.
Interventions
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13 valent pneumococcal conjugate vaccine
Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.
Eligibility Criteria
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Inclusion Criteria
Group 4 only:
* Negative urine pregnancy test for female subjects who are menstruating.
Exclusion Criteria
Group 4 only:
* Previous vaccination with Prevnar or any other pneumococcal vaccine.
* Pregnant or breastfeeding adolescent females.
15 Months
17 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Benton, Arkansas, United States
Pfizer Investigational Site
Fayetteville, Arkansas, United States
Pfizer Investigational Site
Jonesboro, Arkansas, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Fountain Valley, California, United States
Pfizer Investigational Site
Loma Linda, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Marietta, Georgia, United States
Pfizer Investigational Site
DeKalb, Illinois, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Saint Paul, Minnesota, United States
Pfizer Investigational Site
Lebanon, New Hampshire, United States
Pfizer Investigational Site
Whitehouse Station, New Jersey, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Cary, North Carolina, United States
Pfizer Investigational Site
Bismarck, North Dakota, United States
Pfizer Investigational Site
Fargo, North Dakota, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Tulsa, Oklahoma, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Clarksville, Tennessee, United States
Pfizer Investigational Site
Galveston, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Murray, Utah, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
South Jordan, Utah, United States
Pfizer Investigational Site
Vienna, Virginia, United States
Pfizer Investigational Site
Vancouver, Washington, United States
Pfizer Investigational Site
Monroe, Wisconsin, United States
Countries
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References
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Frenck R Jr, Thompson A, Senders S, Harris-Ford L, Sperling M, Patterson S, Devlin C, Jansen KU, Gruber WC, Emini EA, Scott DA, Gurtman A. 13-Valent pneumococcal conjugate vaccine in older children and adolescents either previously immunized with or naive to 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Feb;33(2):183-9. doi: 10.1097/INF.0000000000000056.
Frenck R Jr, Thompson A, Yeh SH, London A, Sidhu MS, Patterson S, Gruber WC, Emini EA, Scott DA, Gurtman A; 3011 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children previously immunized with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2011 Dec;30(12):1086-91. doi: 10.1097/INF.0b013e3182372c6a.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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6096A1-3011
Identifier Type: -
Identifier Source: org_study_id
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