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

Immunogenicity and Safety of Meningococcal (Groups A, C, Y, and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Adolescents in the US When Administered Concomitantly With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap Vaccine)

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:

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.

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.