Dose Comparison Study of Menactra® in US Children

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.