Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

Inclusion Criteria:

- Healthy, as determined by medical history and physical examination.

- Aged 4 to < 7 years at the time of study vaccination on Day 0.

- Informed consent form that has been approved by the Institutional Review Board (IRB)
and signed/dated by the parent or legal guardian.

- Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular
pertussis (DTaP) series.

Exclusion Criteria:

- Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic,
psychiatric, hematologic)

- Known or suspected impairment of immunologic function

- Acute medical illness with or without fever within the last 72 hours or temperature ≥
100.4°F (≥ 38°C) at the time of enrollment

- History of documented invasive meningococcal disease or previous meningococcal
vaccination

- Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or
4th dose of IPV prior to this study.

- Received either immune globulin or other blood products within the last 3 months; or
received injected or oral corticosteroids, or other immunomodulator therapy, within 6
weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids
lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral
steroids lasting 3 to 4 days may be included in the trial as long as they have not
received more than one course within the last 2 weeks prior to enrollment.

- Received oral or injected antibiotic therapy within the 72 hours prior to any blood
draw.

- Suspected or known hypersensitivity to any of the study vaccine components, history of
serious or life-threatening reaction to the trial vaccines or a vaccine containing the
same substances.

- Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.

- Unavailable for the entire study period, or unable to attend the scheduled visits or
to comply with the study procedures.

- Enrolled in another clinical trial.

- Diagnosed with any condition, which, in the opinion of the physician investigator,
would pose a health risk to the subject or interfere with the evaluation of the
vaccine.

- Received any other vaccine 30 days prior to the first study vaccination or scheduled
to receive any vaccination during the course of the study.

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