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

Exclusion Criteria

• •An individual fulfilling any of the following criteria was to be excluded from trial enrollment:
• •Participation at the time of study enrollment or in the 4 weeks preceding the first 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 first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• •Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., meningitis polysaccharide or meningitis Conjugate vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
• •Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type 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 of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
• •Family history of congenital or hereditary immunodeficiency until the immune competence of the potential vaccine recipient is demonstrated.
• •Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms 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 not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
• •History of intussusception.
• •History of any neurologic disorders, including seizures (febrile and non-febrile) and progressive neurologic disorders.
• •History of Guillain-Barré syndrome.
• •Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast.
• •Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigator'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 blood draw.
• •Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
• •Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
• •Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>= 38.0 degree Celsius \[°C\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
• •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
• •* For the Russian Federation, febrile illness was defined as temperature \>= 37°C. A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
• •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.