A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine (TetraMen-T) in Infants and Toddlers

Participants will receive study vaccinations beginning at age 2, 6, or 12 months, depending
on the assigned schedule in their randomized groups. All participants will undergo safety
and immunogenicity assessments according to the schedule for their assigned group.

Inclusion Criteria :

- Groups 1, 2, 3, 6, and 7: Aged 42 to 89 days on the day of inclusion; Group 4: Aged 6
months (180 days ± 14 days) on the day of inclusion; Group 5: Aged 12 months (365
days + 14 days) on the day of inclusion

- 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 or other legally
acceptable representative

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

- Group 4 only: Prior receipt of Pentacel and Prevnar at 2 and 4 months; 1 or 2 doses
of rotavirus vaccine; and 2 or 3 previous doses of hepatitis B vaccine Group 5 only:
Prior receipt of Pentacel and Prevnar at 2, 4, and 6 months; 2 or 3 doses of
rotavirus vaccine; and 3 previous doses of hepatitis B vaccine

Exclusion Criteria :

- Participation in another clinical trial investigating a vaccine, drug, medical
device, or medical procedure in the 4 weeks preceding the first trial vaccination

- Planned participation in another clinical trial during the present trial period

- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination

- Planned receipt of any vaccine in the 4 weeks following any trial vaccination, with
the exception of influenza vaccine, which may be received 14 days before or after
TetraMen-T vaccine

- Previous vaccination against meningococcal disease with either the trial vaccine or
another vaccine

- Receipt of blood or blood-derived products in the past 30 days, which might interfere
with assessment of the immune response

- 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)

- Known personal or maternal seropositivity for human immunodeficiency virus (HIV),
hepatitis B vaccine, or hepatitis C, as reported by the parent/guardian

- History of meningococcal infection, confirmed either clinically, serologically, or
microbiologically

- At high risk for meningococcal infection during the trial

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccines used in the trial or to a vaccine
containing any of the same substances

- Thrombocytopenia, as reported by the parent/guardian

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular vaccination

- History of seizures

- Personal or family history of Guillain-Barré Syndrome (GBS)

- Chronic illness that, in the opinion of the investigator, is at a stage where it
might interfere with trial conduct or completion

Temporary contraindications to be resolved before vaccination:

- Febrile illness (temperature ≥38.0°C [≥100.4°F]) or moderate or severe acute
illness/infection (according to investigator judgment) on the day of vaccination

- Group 5 only: Receipt of oral or injected antibiotic therapy within the 72 hours
prior to the study blood draw. Topical antibiotics or antibiotic drops are not
included in this exclusion criterion. (Note: This does not apply to the other groups
at this time, as they will not be having a blood draw within 30 days of the initial
visit.)