New quadrivalent meningitis vaccine shows promise in large pediatric trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * For Cohort I: Aged 7 to 17 years on the day of inclusion ("7 to 17 years" means from the day of the 7th birthday to the day before the 18th birthday.). For Cohort II: Aged 2 to 6 years on the day of inclusion (2 to 6 years" means from the day of the 2nd birthday to the day before the 7th birthday.) * Participants who are healthy as determined by medical evaluation including medical history and physical examination. * A female participant is eligible to participate if she is not pregnant or breastfeeding Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * 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.