Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children

Eligible participants will receive one injection of either Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine or Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine and will be monitored for safety and immunogenicity for up to 30 days post-vaccination.

Inclusion criteria

• Aged 2 to 6 years on the day of inclusion
• Informed consent form has been signed and dated by the parent or another legally acceptable representative
• Subject and parent/ legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
• Written documentation of immunization history against meningococcal disease according to the national Expanded Program on Immunization (EPI) schedule (including 2 doses with Meningococcal Group A Polysaccharide Vaccine between 6 and 18 months of age).

Exclusion criteria

• Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination (except for influenza vaccination, which may be received at least 2 weeks before study vaccines)
• Previous vaccination against meningococcal disease within the past 12 months with either the trial vaccine or another vaccine
• Previous vaccination with any meningococcal conjugate vaccine.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
• At high risk for meningococcal disease during the trial, including:

• persons with increased susceptibility such as persistent complement component deficiencies,
• persons with anatomic or functional asplenia,
• persons who have exposure (e.g., microbiologists routinely working with N. meningitidis, or travelers to or residents of areas where meningococcal disease is hyperendemic or epidemic)
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
• Known thrombocytopenia, as reported by the parent/ legally acceptable representative, contraindicating intramuscular vaccination
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• 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 (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• Receipt of oral or injected antibiotic therapy within 72 hours before the first blood draw
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
• Any contraindication as listed in the study vaccines leaflets.