Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Polysaccharide Diphtheria Conjugate Vaccine; Polysaccharide Diphtheria Conjugate Vaccine; Polysaccharide Diphtheria Conjugate Vaccine; Polysaccharide Diphtheria Conjugate Vaccine
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
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: 234.0
Sex: All
Minimum age: 7 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal infection; Neisseria meningitidis; Menactra®; Menomune®

Summary:

      The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged
      7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study
      603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of
      participants who will receive a booster dose of Menactra® vaccine and children in the same
      age group not previously vaccinated with a meningococcal vaccine or had meningitis disease
      who will receive a dose of Menactra® vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is healthy, as determined by medical history.

          -  Subject is between the ages of 7 and 15 years (not yet 16 years).

          -  For subjects who participated in Study 603-02, subject previously received one dose of
             Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.

          -  The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months
             before the collection of the blood sample obtained for Study MTA23.

          -  A negative urine pregnancy test is required for menstruating female subjects.

          -  Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed
             consent form and subject has signed an IRB-approved assent form.

        Exclusion Criteria:

          -  Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects
             from Study 603-02 who had been recruited for the follow-up challenge study)

          -  History of documented invasive meningococcal disease

          -  Received any other meningococcal vaccine

          -  Received any vaccine in the 28-day period prior to enrollment

          -  Received antibiotic therapy within the 72 hours prior to collection of a blood sample

          -  Actively enrolled or scheduled to be enrolled in another clinical study

          -  Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic,
             gastrointestinal, psychiatric, or other organ system)

          -  Known or suspected impairment of immunologic function

          -  Acute medical illness with or without fever within 72 hours or an oral temperature ≥
             100.4°F (≥ 38.0°C) at the time of inclusion

          -  Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment

          -  Administration of immune globulin, other blood products, or corticosteroid within 8
             weeks (56 days) 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.

          -  Personal of family history of Guillain-Barres Syndrome

          -  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

          -  Any condition which, in the opinion of the investigator, would pose a health risk to
             the participant.