study of a booster dose of meningococcal diphtheria toxoid conjugate vaccine in adolescents

Conditions: Meningitis; Meningococcemia

Summary: this study was designed to evaluate the antibody response to a menactra® booster dose in participants who previously received one dose of menactra® or menomune® as adolescents 3 years earlier in study mta02. primary objective: to evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (menactra®) in participants who had previously received menactra® or menomune® as adolescents in the mta02 study and antibody responses to a dose of menactra® in naive adolescents.

all subjects were given a single boosting dose of menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.

Eligibility criteria:
inclusion criteria : * participant is healthy, as determined by medical history and physical examination. * participant is at least 13 years of age but not yet 22 years of age at time of enrollment. * for the menactra® and menomune® groups, participant received one dose of menactra® or menomune® in mta02 trial and completed trial (2 blood samples, contacted for month 6 safety follow up). * for the control group, participant has no previous history of any meningococcal vaccination. * if \< 18 years of age, participant has signed institutional review board (irb) approved informed assent form and his/her parent/legal guardian has signed an irb-approved informed consent form. * if ≥ 18 years of age, participant has signed an irb-approved informed consent form. * able to provide vaccination log. 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 ≥ 100.4ºf (≥ 38.0ºc) at the time of inclusion. * for the menactra® and menomune® groups, history of documented invasive meningococcal disease or previous meningococcal vaccination with the exception of meningococcal vaccination given as part of mta02 trial. * for the control group, history of documented invasive meningococcal disease or previous meningococcal vaccination. * administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. * antibiotic therapy within the 72 hours prior to vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn. * received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination. * suspected or known hypersensitivity to any of the vaccine components. * unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures. * in females, a positive or equivocal urine pregnancy test at the time of vaccination. * enrolled in another clinical trial. * any condition, which, in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the vaccine.

Keywords: meningitis meningococcemia neisseria meningitidis