Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents
Condition: Meningitis; Meningococcemia
MeSH terms: Diphtheria; Meningitis
Intervention: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 241.0
Sex: All
Minimum age: 13 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcemia; Neisseria meningitidis

Summary:

      This study was designed to evaluate the antibody response to a Menactra® booster dose in
      participants who previously received one dose of Menactra® or Menomune® as adolescents 3
      years earlier in Study MTA02.

      Primary Objective:

      To evaluate the antibody responses to a booster dose of a tetravalent meningococcal
      diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received
      Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of
      Menactra® in naive adolescents.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Participant is healthy, as determined by medical history and physical examination.

          -  Participant is at least 13 years of age but not yet 22 years of age at time of
             enrollment.

          -  For the Menactra® and Menomune® groups, participant received one dose of Menactra® or
             Menomune® in MTA02 trial and completed trial (2 blood samples, contacted for Month 6
             safety follow up).

          -  For the Control group, participant has no previous history of any meningococcal
             vaccination.

          -  If < 18 years of age, participant has signed Institutional Review Board (IRB) approved
             informed assent form and his/her parent/legal guardian has signed an IRB-approved
             informed consent form.

          -  If ≥ 18 years of age, participant has signed an IRB-approved informed consent form.

          -  Able to provide vaccination log.

        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 oral
             temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of inclusion.

          -  For the Menactra® and Menomune® groups, history of documented invasive meningococcal
             disease or previous meningococcal vaccination with the exception of meningococcal
             vaccination given as part of MTA02 trial.

          -  For the Control group, history of documented invasive meningococcal disease or
             previous meningococcal vaccination.

          -  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 14-day period prior to study vaccination, or scheduled to
             receive any vaccination during the 14-day period after study vaccination.

          -  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.

          -  In females, a positive or equivocal urine pregnancy test at the time of vaccination.

          -  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.