Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age

Completed · Phase 2

Conditions studied: Meningitis, Meningococcal Infection

In brief

The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.

Key facts

Study ID

NCT00643916

Run by

Sanofi Pasteur, a Sanofi Company

People needed

378

Starts

2004-12-01

Expected to finish

2007-10-01

Last updated by the study team

2014-02-14

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged either 9, 12, 15 or 18 months of age or 3 to < 6 years of age on the day of inclusion.
• Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian
• Able to attend all scheduled visits and to comply with all trial procedures

You may not qualify if…

• History of a serious chronic disease that could interfere with trial conduct or completion.
• Known or suspected impairment of immunologic function.
• Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion.
• History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.
• Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
• Antibiotic therapy within the 72 hours prior to having any blood sample drawn.
• Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine.
• Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• Unable to attend one or more of the scheduled visits or to comply with the study procedures.
• Participation in another clinical trial in the 4 weeks preceding enrollment.
• Planned participation in another clinical trial during the present trial period.
• 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 — Little Rock, Arkansas, United States
• Study site — Norwich, Connecticut, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Woburn, Massachusetts, United States
• Study site — Akron, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Drexel Hill, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Sellersville, Pennsylvania, United States
• Study site — Kingsport, Tennessee, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.