Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
NCT ID: NCT00355121
Last Updated: 2011-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
882 participants
INTERVENTIONAL
2006-10-31
2009-07-31
Brief Summary
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The main objectives are:
Immunogenicity:
To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone.
Safety:
To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1
DAPTACEL® + IPOL on Day 0 and Menactra on Day 30
Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
Group 2
DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30
Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
Group 3
Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30
Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
Interventions
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Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 4 to \< 7 years at the time of study vaccination on Day 0.
* Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian.
* Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.
Exclusion Criteria
* Known or suspected impairment of immunologic function
* Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment
* History of documented invasive meningococcal disease or previous meningococcal vaccination
* Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study.
* Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment.
* Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw.
* Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances.
* Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.
* Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
* Enrolled in another clinical trial.
* Diagnosed with any condition, which, in the opinion of the physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
* Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study.
* Personal or family history of Guillain-Barré Syndrome (GBS).
4 Years
7 Years
ALL
Yes
Sponsors
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Sanofi
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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Little Rock, Arkansas, United States
Boulder, Colorado, United States
Atlanta, Georgia, United States
Layton, UT 84041, Georgia, United States
Bardstown, Kentucky, United States
Woburn, Massachusetts, United States
Bridgeton, Missouri, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Rochester, New York, United States
Syracuse, New York, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
University Heights, Ohio, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Kingsport, Tennessee, United States
Layton, Utah, United States
Ogden, Utah, United States
Pleasant Grove, Utah, United States
Provo, Utah, United States
Salt Lake City, Utah, United States
South Jordan, Utah, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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MTA43
Identifier Type: -
Identifier Source: org_study_id
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