Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Inclusion criteria:

• Aged >= 42 to <= 89 days on the day of the first study visit.
• Healthy infants as determined by medical history, physical examination, and judgmentof the investigator.
• Informed consent form was signed and dated by the parent(s) or guardian (and by anindependent witness if required by local regulations).
• Participant and parent/guardian were able to attend all scheduled visits and compliedwith all trial procedures.
• Infants who received the first dose of hepatitis B vaccine at least 28 days before thefirst study visit.

Exclusion criteria:

• 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 might be received at least 2 weeks before or 2weeks after any study vaccination. This exception includes monovalent pandemicinfluenza vaccines and multivalent influenza vaccines.
• Previous vaccination against meningococcal disease with either the trial vaccine oranother vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcalvaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containingvaccine).
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitisA, measles, mumps, rubella, varicella; and Haemophilus influenzae type b,Streptococcus pneumoniae, and /or rotavirus infection or disease.
• Receipt of 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 was 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, varicella, Haemophilus influenzae type b, Streptococcuspneumoniae, 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 and progressive neurologicdisorders.
• 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 vaccine(s) 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.
• Chronic illness (including, but not limited to, cardiac disorders, congenital heartdisease, chronic lung disease, renal disorders, auto-immune disorders, diabetes,psychomotor diseases, and known congenital or genetic diseases) that in the opinion ofthe investigator, is at a stage where it might interfere with trial conduct orcompletion.
• 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 degree Celsius [>= 100.4-degree Fahrenheit]). A prospective participant should not be included in thestudy until the condition has resolved or the febrile event has subsided.
• Identified as a natural or adopted child of the Investigator or employee with directinvolvement in the proposed study. The above information was not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.