Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants

Inclusion Criteria:

• Aged 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3)on the day of inclusion

• For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with abirth weight ≥ 2.5 Kg or born after a gestation period of period above 28 (> 28weeks) through 36 weeks with a birth weight ≥ 1.5 Kg and in both cases medicallystable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not requiresignificant medical support or ongoing management for debilitating disease and whohave demonstrated a clinical course of sustained recovery by the time they receivethe first dose of study intervention

• Participants who are overtly healthy as determined by medical evaluation includingmedical history, physical examination, and judgement of the investigator

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,within the preceding 6 months or since birth for infants; or long-term systemiccorticosteroid therapy (prednisone or equivalent for more than 2 consecutive weekswithin the past 3 months or since birth for and infants)

• History of any meningitis infection, confirmed either clinically, serologically, ormicrobiologically

• At high risk of meningococcal infection during the study

• Known systemic hypersensitivity to any of the study intervention components, orhistory of a life-threatening reaction to the study interventions used in the studyor to a product containing any of the same substances

• Individual with active tuberculosis

• History of Guillain-Barré syndrome

• For Stage 3 infants: History of intussusception

• Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with aninvestigational or marketed vaccine

• For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28days before the first trial vaccination

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.