study of menactra® in us adolescents when administered concomitantly with tdap vaccine

Conditions: Meningitis; Meningococcemia; Pertussis; Tetanus; Diphtheria

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: 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.


Eligibility criteria:
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.

Keywords: meningitis meningococcemia pertussis neisseria meningitidis tetanus diphtheria