study of menactra® in children aged 4 to 6 years when administered concomitantly with a fifth dose of daptacel®

Conditions: Meningococcal Meningitis; Tetanus; Diphtheria; Pertussis; Poliomyelitis

Summary: the purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of menactra® vaccine and daptacel® vaccine. the main objectives are: immunogenicity: to evaluate the antibody responses to both vaccines when menactra vaccine is given concomitantly with daptacel® compared to when either vaccine is given alone. safety: to evaluate the rate of local and systemic reactions when daptacel® and menactra vaccines are administered concomitantly compared to when each vaccine is given alone.


Eligibility criteria:
inclusion criteria: * healthy, as determined by medical history and physical examination. * aged 4 to \< 7 years at the time of study vaccination on day 0. * informed consent form that has been approved by the institutional review board (irb) and signed/dated by the parent or legal guardian. * previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (dtap) series. exclusion criteria: * serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic) * known or suspected impairment of immunologic function * acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°f (≥ 38°c) at the time of enrollment * history of documented invasive meningococcal disease or previous meningococcal vaccination * received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of ipv prior to this study. * 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 enrollment. * received oral or injected antibiotic therapy within the 72 hours prior to any blood draw. * suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances. * thrombocytopenia or a bleeding disorder contraindicating im vaccination. * 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 physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. * received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study. * personal or family history of guillain-barré syndrome (gbs).

Keywords: meningococcal meningitis tetanus diphtheria pertussis poliomyelitis neisseria meningitidis