Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26
Condition: Meningitis; Meningococcemia
MeSH terms: Meningitis
Intervention: Meningococcal polysaccharide diphtheria toxoid conjugate; Meningococcal polysaccharide diphtheria toxoid conjugate; Meningococcal polysaccharide diphtheria toxoid conjugate
Intervention description: 0.5 mL, IM; 0.5 mL, IM; 0.5 mL, IM
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 3 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcemia; Neisseria meningitidis; Menactra®

Summary:

      Study will evaluate the persistence of antibodies approximately three years after an initial
      dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and
      age-matched Menactra naive participants.

      Objectives:

        -  To assess the persistence of antibody responses three years after one or two doses of
           Menactra® vaccine in subjects who participated in study MTA26.

        -  To describe the antibody responses to a single dose of Menactra® vaccine in subjects who
           had previously received one or two doses of Menactra® vaccine and in Menactra®
           vaccine-naïve subjects.

        -  To describe the safety profile of a single dose of Menactra® vaccine in subjects.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Subjects received one or two doses of Menactra® vaccine in study MTA26 and provided a
             blood sample after the last dose received

          -  At 3 to < 6 years of age and were never vaccinated against meningococcal disease (with
             either the study vaccine or another vaccine).

          -  Informed consent form signed and dated by the parent(s) or another legally acceptable
             representative.

          -  Subject and parent/legal guardian able to attend all scheduled visits and comply with
             all study procedures.

        Exclusion Criteria :

          -  Participation in the active (i.e., treatment) portion of another clinical trial
             investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks
             preceding the first study vaccination

          -  Planned participation in another clinical trial during the present trial period.

          -  Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
             such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
             or long-term systemic corticosteroids therapy.

          -  Known or suspected systemic hypersensitivity to any of the vaccine components, or
             history of a life-threatening reaction to the study vaccine or to a product containing
             any of the substances present in the study vaccine.

          -  Chronic illness at a stage that could interfere with trial conduct or completion, in
             the opinion of the investigator.

          -  Received blood or blood-derived products in the past 3 months.

          -  Received any vaccine (other than desensitization therapy for allergies or influenza
             vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first study
             vaccination.

          -  Planned receipt of any vaccine within the 4 weeks following the study vaccination.

          -  Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen),
             or hepatitis C seropositivity.

          -  History of invasive meningococcal infection (confirmed either clinically,
             serologically, or microbiologically).

          -  Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding
             inclusion contraindicating intramuscular (IM) vaccination.

          -  Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior
             to any of the trial blood draws.

          -  Personal or family history of Guillain-Barré Syndrome (GBS).

          -  Any condition which, in the opinion of the investigator, would pose a health risk to
             the subject or interfere with the evaluation of the vaccine.