Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico

Inclusion criteria: An individual must fulfill all of the following criteria in order to be eligible for trialenrollment:

• Infants 2 months of age (60 to 89 days of age) on the day of the first study visit.*
• Born after a full-term pregnancy, with an estimated gestation age >= 37 weeks and abirth weight >= 2.5 kilograms.
• Informed consent form has been signed and dated by the parent(s) or guardian(s), asrequired by local regulations.†
• Participant and parent/guardian were able to attend all scheduled visits and to complywith all trial procedures.
• In good health as determined by medical history and physical assessment.
• For the Russian Federation: The participant's parents were able to verbally report orprovide written documentation that the participant's mother was hepatitis B antigennegative during pregnancy with the participant.
• • "2 months" means from the 2nd month after birth to the day before the 3rd monthafter birth (2 months to 2 months 29 days); "60 days" means from the 60th dayafter birth to the day before the 90th day after birth (60 to 89 days).
• † In the Russian Federation, as per local regulations, only theparticipant's parent(s) were entitled to sign an informed consent form. Achild under the responsibility of a guardian would not be included in thestudy.

Exclusion criteria: An individual fulfilling any of the following criteria was to be excluded from trialenrollment:

• Participation at the time of study enrollment or in the 4 weeks preceding the firsttrial vaccination or planned participation during the present trial period in anotherclinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or plannedreceipt of any vaccine in the 4 weeks before and/or following any trial vaccinationexcept for influenza vaccination, which may be received at a gap of at least 2 weeksbefore or 2 weeks after any study vaccination. This exception includes monovalentpandemic influenza vaccines and multivalent influenza vaccines.
• Previous vaccination against meningococcal disease with either the trial vaccine oranother vaccine (i.e., meningitis polysaccharide or meningitis Conjugate vaccinecontaining serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
• Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzaetype b (Hib), poliovirus, rotavirus, Streptococcus pneumoniae, measles, mumps,rubella, and / or varicella.
• For Mexico: More than 1 previous dose of hepatitis B vaccine.
• Receipt of immune globulins, blood or blood-derived products since birth.
• Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; orlong-term systemic corticosteroid therapy (prednisone or equivalent for more than 2consecutive weeks) since birth.
• Family history of congenital or hereditary immunodeficiency until the immunecompetence of the potential vaccine recipient is demonstrated.
• Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignantneoplasms affecting the bone marrow or lymphatic systems.
• Individuals with active tuberculosis.
• History of any Neisseria meningitidis infection, confirmed either clinically,serologically, or microbiologically.
• History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A,measles, mumps, rubella, Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection / disease.
• At high risk for meningococcal infection during the trial (specifically, but notlimited to, participants with persistent complement deficiency, with anatomic orfunctional asplenia, or participants traveling to countries with high endemic orepidemic disease).
• History of intussusception.
• History of any neurologic disorders, including seizures (febrile and non-febrile) andprogressive neurologic disorders.
• History of Guillain-Barré syndrome.
• Known systemic hypersensitivity to any of the vaccine components or to latex, orhistory of a life-threatening reaction to the vaccines used in the trial or to avaccine containing any of the same substances, including neomycin, gelatin, and yeast.
• Verbal report of thrombocytopenia contraindicating intramuscular vaccination in theInvestigator's opinion.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating intramuscular vaccination in the Investigator's opinion.
• Receipt of oral or injectable antibiotic therapy within 72 hours of the first blooddraw.
• Chronic illness that, in the opinion of the Investigator, is at a stage where it mightinterfere with trial conduct or completion.
• Any condition which, in the opinion of the Investigator, might interfere with theevaluation of the study objectives.
• Moderate or severe acute illness/infection (according to Investigator judgment) on theday of vaccination or febrile illness (temperature >= 38.0 degree Celsius [°C]). Aprospective participant should not be included in the study until the condition hadresolved or the febrile event had subsided.
• Identified as a natural or adopted child of the Investigator or employee with directinvolvement in the proposed study.
• For the Russian Federation, febrile illness was defined as temperature >= 37°C. Aprospective participant should not be included in the study until the conditionhad resolved or the febrile event had subsided. The above information was not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.