Dose Comparison Study of Menactra® in US Children
Condition: Meningitis; Meningococcal Infection; Neisseria Meningitidis
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate; Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate; Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
Intervention description: 0.5 mL, 2 doses Intramuscular; 0.5 mL, 2 doses Intramuscular; 0.5 mL, 1 dose Intramuscular
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 333.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal infection, Neisseria meningitidis

Summary:

      To explore the potential benefit of the administration of Menactra vaccine as a two-dose
      regimen to children.

      Primary Objective:

      To assess, by age group, the immune response to Menactra vaccine after each vaccine
      injection.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Aged 2 to < 11 years on the day of inclusion.

          -  Provision of assent form signed by the subject (depending on age) and informed consent
             form signed by the parent(s) or another legally acceptable representative.

          -  Subject and parent/legal guardian able to attend all scheduled visits and comply with
             all trial procedures.

        Exclusion Criteria :

          -  Previous vaccination against meningococcal disease with either the trial vaccine or
             another vaccine.

          -  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 trial 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.

          -  Suspected or known systemic hypersensitivity to any of the vaccine components, or
             history of a life-threatening reaction 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.

          -  Receipt of 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 trial
             vaccination.

          -  Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).

          -  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.