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

Inclusion criteria :

• Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the firstvisit

• Informed consent form has been signed and dated by the parent(s) or other guardianand by an independent witness if required by local regulations

• Subject and parent/guardian are able to attend all scheduled visits and to complywith all trial procedures

• For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documentedhistory of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV),pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 monthsof age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines

• For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4),documented history of having received all routine pediatric vaccines recommended bythe Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment

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 inanother clinical trial investigating a vaccine, drug, medical device, or medicalprocedure

• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination orplanned receipt of any vaccine in the 4 weeks before and / or following any trialvaccination except for influenza vaccination, which may be received 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., mono- or polyvalent, polysaccharide, or conjugatemeningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal Bserogroup-containing vaccine)

• For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), priorreceipt of more than 2 doses of rotavirus vaccine (Rotateq), DTaP, Hib, IPV,pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 monthsof age, prior receipt of more than 3 doses of hepatitis B vaccine)

• For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receiptof the 2 doses of rotavirus vaccine at 2 and 4 months of age

• Receipt of immune globulins, blood, or blood-derived products in the past 3 months

• Known or suspected congenital or acquired immunodeficiency or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapywithin the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3months

• 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 othermalignant 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, varicella; and of Haemophilus influenzae type b,Streptococcus pneumoniae, and /or rotavirus infection or disease

• At high risk for meningococcal infection during the trial (specifically, but notlimited to, subjects with persistent complement deficiency, with anatomic orfunctional asplenia, or subjects travelling to countries with high endemic orepidemic disease)

• History of intussusception

• History of any neurologic disorders, including any seizures and progressiveneurologic disorders

• History of Arthus-type hypersensitivity reaction after a previous dose of tetanustoxoid-containing vaccine

• 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, andyeast

• 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 prior to the firstblood draw

• Chronic illness that, in the opinion of the investigator, is at a stage where itmight interfere 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) onthe day of vaccination or febrile illness (temperature ≥ 38.0 C [≥ 100.4 F]). Aprospective subject should not be included in the study until the condition hasresolved 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.