Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age

Participants will be vaccinated according to their randomized groups at age 9 months and at
age 15 to 18 months. They will undergo immunogenicity assessment and safety monitoring
post-vaccination.

Inclusion Criteria:

- Aged 9 months (249 to 305 days) for Groups 1 and 2, or 15 to 18 months (420 to 570
days) for Group 3 on the day of the first trial visit

- Informed consent form has been signed and dated by the parent(s) or other legally
acceptable representative

- Received 3 doses of any DTaP-containing vaccines

- Received 3 doses of a Hib-containing vaccine, or 2 doses if the subject received
PRP-OMP (PedvaxHIB® or Comvax®[HepB-Hib])

- Received at least 3 doses of a CRM197-based pneumococcal conjugate vaccine
(Pneumococcal conjugate vaccine [PCV] or 13-Valent pneumococcal conjugate vaccine
[PCV13])

- Subject and parent/ legally acceptable representative are able to attend all
scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

- Participation 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 each trial vaccination or planned
receipt of any vaccine in the 4 weeks following each trial vaccination, except for
influenza vaccination, which may be received at least 2 weeks before or after the
trial vaccination(s)

- Vaccination against meningococcal disease with either the trial vaccine or another
vaccine, or receipt of the 4th dose of any DTaP-containing vaccines, receipt of the
4th dose of a Hib-containing vaccine, or receipt of the 3rd dose of PRP-OMP
(PedvaxHIB® or Comvax® [Hep B-Hib]) prior to enrollment or during the conduction of
the trial, except for Group 1 subjects, who may receive Hib vaccine at 12 months

- 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). Topical steroids are not included in this exclusion criterion

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

- Personal history of Guillain-Barré Syndrome

- History of encephalopathy (e.g., coma, decreased level of consciousness, prolonged
seizures) within 7 days of a previous dose of a pertussis containing vaccine that is
not attributable to another identifiable cause

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

- Known thrombocytopenia, as reported by the parent/ legally acceptable representative,
contraindicating intramuscular vaccination

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

- In an emergency setting or hospitalized involuntarily

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

- Moderate or severe acute illness/ infection (according to investigator judgment) or
febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) on the day of vaccination. A
prospective subject should not be included in the trial until the condition has
resolved or the febrile event has subsided

- Receipt of oral or injectable antibiotic therapy within 72 hours prior to any trial
blood draw (topical antibiotics, drops, or ointments are not included in this
criterion)

- Identified as a natural or adopted child of the Investigator or employee with direct
involvement in the proposed trial.