Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine

Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD

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.

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.