Status:
COMPLETED
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningitis
Meningococcemia
Eligibility:
All Genders
11-17 years
Phase:
PHASE4
Brief Summary
The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Primary Objective: ...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Healthy as determined by medical history and physical examination.
- 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 :
- Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
1345 Patients enrolled
Trial Details
Trial ID
NCT00777257
Start Date
April 1 2005
End Date
September 1 2007
Last Update
February 14 2014
Active Locations (20)
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1
Jonesboro, Arkansas, United States, 72401
2
Little Rock, Arkansas, United States, 72205
3
Boulder, Colorado, United States, 80303
4
Marietta, Georgia, United States, 30062