Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
NCT ID: NCT00777257
Last Updated: 2014-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1345 participants
INTERVENTIONAL
2005-04-30
2007-09-30
Brief Summary
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Primary Objective:
To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately.
Secondary Objective:
To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Study Group A
Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular
Study Group B
Tdap vaccine + Menactra® vaccine concomitantly on Day 0; placebo 28 days later
Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular
Study Group C
Menactra® vaccine + placebo concomitantly on Day 0; Tdap vaccine 28 days later
Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular
Interventions
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T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular
Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular
Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.
* Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.
* Informed assent form that has been approved by the IRB signed by the subject.
* Subject (female) agrees to use measures to prevent pregnancy during the study.
Exclusion Criteria
* Known or suspected impairment of immunologic function.
* Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.
* History of documented invasive meningococcal disease or previous meningococcal vaccination.
* History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.
* 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 enrolment.
* Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.
* Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.
* Suspected or known hypersensitivity to either of the two study vaccines or their components.
* 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 investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
* For all females, a positive or equivocal urine pregnancy test at time of study vaccination.
* Nursing mothers.
11 Years
17 Years
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 Monitor
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Boulder, Colorado, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
Bardstown, Kentucky, United States
Baltimore, Maryland, United States
Woburn, Massachusetts, United States
Albuquerque, New Mexico, United States
Syracuse, New York, United States
Raleigh, North Carolina, United States
Sylva, North Carolina, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Kingsport, Tennessee, 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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MTA21
Identifier Type: -
Identifier Source: org_study_id
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