Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
Meningococcal Meningitis, Tetanus, Diphtheria
About this trial
This is an interventional prevention trial for Meningococcal Meningitis focused on measuring Meningococcal meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis, Neisseria meningitidis
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group 1
Group 2
Group 3
DAPTACEL® + IPOL on Day 0 and Menactra on Day 30
DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30
Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30