study of reduced dose of menomune® in children who previously received meningococcal diphtheria toxoid conjugate vaccine

Conditions: Meningitis; Meningococcemia; Neisseria Meningitidis

Summary: this study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides a, c, y, and w-135, menomune® in children who were vaccinated with one dose of tetramend at least 18 months earlier. primary objective: to evaluate and compare the antibody responses to a reduced dose of menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of menomune® but had not previously received any meningococcal vaccine.

this was a two stage, controlled, open-label trial. stage i of the trial simulated meningococcal challenge stage ii of the trial evaluated the meningococcal vaccine naïve participants from stage i, who had also received a reduced dose of menomune® vaccine in stage i and were administered a full dose of menactra® vaccine 6 months later.

Eligibility criteria:
inclusion criteria : * stage i * participant is healthy, as determined by medical history and physical examination. * participant is at least 3 years of age but not yet 6 years of age at the enrolment. * for the tetramend group: received one dose of tetramend as a participant in trial 603-02 no less than 18 months prior to enrolment * for the control group: no previous history of any meningococcal vaccination * parent/guardian has signed institutional review board- (irb-) approved informed consent form. * stage ii * participant is healthy, as determined by medical history and physical examination. * participant is at least 3 years of age but not yet 6 years of age at the time of enrollment in stage 1. * enrolled in the control group only and received one dose of the reduced dose menomune at stage 1. * parent/guardian has signed institutional review board- (irb-) approved informed consent form. 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 axillary temperature (≥ 99.5ºf \[≥ 37.5ºc\]) at the time of inclusion * for stage i, history of documented invasive meningococcal disease or previous meningococcal vaccination with exception of those participants recruited from trial 603-02. * for stage ii, history of documented invasive meningococcal disease or participant did not receive reduced-dose menomune® six months prior. * 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 28-day period prior to study vaccination, or scheduled to receive any vaccination during the 28-day period after study vaccination in stage 1 of the trial. * 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 * 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: menactra® menomune® meningitis meningococcemia neisseria meningitidis