Dose Comparison Study of Menactra® in US Children

This is an open-label trial designed to explore the immune response to a two-dose schedule of
Menactra vaccine compared with a standard one-dose schedule in children.

Inclusion Criteria :

- Aged 2 to < 11 years on the day of inclusion.

- Provision of assent form signed by the subject (depending on age) and informed consent
form signed by the parent(s) or another legally acceptable representative.

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

Exclusion Criteria :

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

- Participation in the active (i.e., treatment) portion of another clinical trial
investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks
preceding the first trial vaccination.

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

- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
or long-term systemic corticosteroids therapy.

- Suspected or known systemic hypersensitivity to any of the vaccine components, or
history of a life-threatening reaction to a product containing any of the substances
present in the study vaccine .

- Chronic illness at a stage that could interfere with trial conduct or completion, in
the opinion of the Investigator.

- Receipt of blood or blood-derived products in the past 3 months.

- Received any vaccine (other than desensitization therapy for allergies or influenza
vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial
vaccination.

- Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).

- Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen),
or hepatitis C seropositivity.

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

- Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding
inclusion contraindicating intramuscular (IM) vaccination.

- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior
to any of the trial blood draws.

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

- Any condition which, in the opinion of the Investigator, would pose a health risk to
the subject or interfere with the evaluation of the vaccine.