Safety and Immune Response of Different Pediatric Combination Vaccines.
NCT ID: NCT00255047
Last Updated: 2014-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2167 participants
INTERVENTIONAL
2005-11-30
2009-02-28
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
NONE
Study Groups
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Study Group 1: DAPTACEL®, ActHIB®, and IPOL®
Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively
DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
0.5 mL, Intramuscular
Study Group 2: Pentacel®
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
Study Group 3: DTaP-IPV and ActHIB®
Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively
DTaP-IPV and ActHIB®
0.5 mL, Intramuscular
Study Group 4: Pentacel®
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
Interventions
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DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
0.5 mL, Intramuscular
Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
DTaP-IPV and ActHIB®
0.5 mL, Intramuscular
Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Born at full term of pregnancy (≥ 36 weeks)
* Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure
* Vaccination with a hepatitis B vaccine at least 30 days before inclusion
* Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone)
* Provide blood sample prior to Dose 1
* Parent or legal representative willing to take rectal temperatures after each vaccination.
Exclusion Criteria
* Planned participation in another clinical trial during the present trial period
* Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s)
* Chronic illness that could interfere with trial conduct or completion
* Received blood or blood-derived products since birth
* Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination
* Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines
* Coagulation disorder contraindicating intramuscular (IM) vaccination
* Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion)
* Developmental delay or neurological disorder
* Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
42 Days
89 Days
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc
Locations
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Tuscaloosa, Alabama, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Fountain Valley, California, United States
Oakland, California, United States
Oakland, California, United States
Oakland, California, United States
Paramount, California, United States
Norwich, Connecticut, United States
Palm Beach Gardens, Florida, United States
Marietta, Georgia, United States
Bardstown, Kentucky, United States
Bossier City, Louisiana, United States
Baltimore, Maryland, United States
Woburn, Massachusetts, United States
Omaha, Nebraska, United States
Ithaca, New York, United States
Liverpool, New York, United States
Huber Heights, Ohio, United States
Youngstown, Ohio, United States
Norristown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Kingsport, Tennessee, United States
Amarillo, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Provo, Utah, United States
South Jordan, Utah, United States
St. George, Utah, United States
Spokane, Washington, United States
Vancouver, Washington, United States
Huntington, West Virginia, United States
Marshfield, Wisconsin, United States
Countries
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References
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Chatterjee A, O'Keefe C, Varman M, Klein NP, Luber S, Tomovici A, Noriega F. Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: a randomized, controlled, open-label, multicenter study. Vaccine. 2012 May 14;30(23):3360-8. doi: 10.1016/j.vaccine.2012.03.057. Epub 2012 Apr 1.
Related Links
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Related Info
Other Identifiers
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M5A10
Identifier Type: -
Identifier Source: org_study_id
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