Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

Exclusion Criteria17

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy; or long-term systemic corticosteroid therapy
• History of meningococcal infection
• History of any neurologic disorders
• History of Guillain-Barré syndrome
• History of an Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
• At high risk for meningococcal infection during the trial
• Known systemic hypersensitivity to any of the vaccine components
• Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
• Moderate or severe acute illness/infection
• Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination.
• The time since last vaccination of meningococcal vaccine was 2 years or less.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.