Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
Condition: Meningitis; Meningococcemia; Neisseria Meningitidis
MeSH terms: Diphtheria; Meningitis
Intervention: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®); A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Intervention description: 0.05 mL, Subcutaneous; 0.05 mL, Subcutaneous
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 173.0
Sex: All
Minimum age: 3 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menactra®; Menomune®; 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.
    

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.