Dose Comparison Study of Menactra® in US Children

Completed · Phase 2

Conditions studied: Meningitis, Meningococcal Infection, Neisseria Meningitidis

In brief

To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children. Primary Objective: To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.

Key facts

Study ID

NCT00700635

Run by

Sanofi Pasteur, a Sanofi Company

People needed

333

Starts

2008-06-01

Expected to finish

2009-10-01

Last updated by the study team

2016-04-14

Who can join

Age: 2 and older, up to 10. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Boca Raton, Florida, United States
• Study site — Viera, Florida, United States
• Study site — Woburn, Massachusetts, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Cleveland, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Kingsport, Tennessee, United States
• Study site — Fort Worth, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Orem, Utah, United States
• Study site — Midlothian, Virginia, United States
• Study site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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