Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

Completed · Phase 4 · Has a placebo group

Conditions studied: Meningitis, Meningococcemia, Pertussis, Tetanus, Diphtheria

In brief

The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Primary Objective: To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately. Secondary Objective: To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.

Key facts

Study ID

NCT00777257

Run by

Sanofi Pasteur, a Sanofi Company

People needed

1345

Starts

2005-04-01

Expected to finish

2007-09-01

Last updated by the study team

2014-02-14

Who can join

Age: 11 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy as determined by medical history and physical examination.
• Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.
• Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.
• Informed assent form that has been approved by the IRB signed by the subject.
• Subject (female) agrees to use measures to prevent pregnancy during the study.

You may not qualify if…

• Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).
• Known or suspected impairment of immunologic function.
• Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.
• History of documented invasive meningococcal disease or previous meningococcal vaccination.
• History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.
• 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 enrolment.
• Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.
• Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.
• Suspected or known hypersensitivity to either of the two study vaccines or their components.
• 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 investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
• For all females, a positive or equivocal urine pregnancy test at time of study vaccination.
• Nursing mothers.

Where it is running

• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Boulder, Colorado, United States
• Study site — Marietta, Georgia, United States
• Study site — Woodstock, Georgia, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Woburn, Massachusetts, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Syracuse, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Sylva, North Carolina, United States
• Study site — Akron, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Sellersville, Pennsylvania, United States
• Study site — Kingsport, Tennessee, United States
• Study site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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