Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 15 Years
Maximum age: 23 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
      15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study
      MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the
      antibody response will be evaluated in a subset of these participants who will receive a
      booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who
      have not been previously vaccinated with a meningococcal vaccine or had documented meningitis
      disease who will also receive a dose of Menactra® vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is healthy, as determined by medical history.

          -  Subject is between the ages of 15 and 23 years (not yet 24 years).

          -  For subjects who participated in Study MTA02, subject previously received one dose of
             Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.

          -  Did not participate in Study MTA19 (a subset of subjects from Study MTA02 who had been
             recruited for a follow-up challenge study)

          -  Subject or parent/legal guardian has signed an Institutional Review Board
             (IRB)-approved informed consent form and subject has signed an IRB-approved assent
             form.

          -  Before recruitment for the second part of the study, subjects should be thoroughly
             screened to ensure that they are able to comply with protocol specifications

          -  A negative urine pregnancy test is required for menstruating female subjects.

        Exclusion Criteria:

          -  History of documented invasive meningococcal disease.

          -  Received any other meningococcal vaccine

          -  Received any vaccine (other than desensitization therapy for allergies) in the 28-day
             period prior to enrollment

          -  Scheduled to receive any vaccination in the 28-day period after enrollment

          -  Received systemic 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, hematologic, 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

          -  Administration of immune globulin, other blood products, or corticosteroid within 3
             months 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 or family history of Guillain-Barre 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.