Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

This is an interventional prevention trial for Meningitis focused on measuring Meningitis, Meningococcemia, Pertussis, Neisseria meningitidis, Tetanus, Diphtheria Read More

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.