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

Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months
in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after
the last vaccination.

Inclusion criteria :

- Aged 6 to 7 months (164 to 224 days) or 17 to 19 months on the day of the first visit

- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

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

- Subject and parent/guardian are able to attend all scheduled visits and to comply with
all trial procedures

- For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented
history 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 months of
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 by
the 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 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 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., mono- or polyvalent, polysaccharide, or conjugate meningococcal
vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing
vaccine)

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

- For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of
the 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 of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy
within the preceding 6 months; or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months

- 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, 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 not
limited to, subjects with persistent complement deficiency, with anatomic or
functional asplenia, or subjects travelling to countries with high endemic or epidemic
disease)

- History of intussusception

- History of any neurologic disorders, including any seizures and progressive neurologic
disorders

- History of Arthus-type hypersensitivity reaction after a previous dose of tetanus
toxoid-containing vaccine

- 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 vaccine(s) 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 prior to 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 C [≥ 100.4 F]). A
prospective subject should not be included in the study until the condition has
resolved or the febrile event has subsided

- Identified as a natural or adopted child of the investigator or employee with direct
involvement 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.