Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

Completed · Phase 4

Conditions studied: Pertussis, Tetanus, Diphtheria

In brief

This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.

Key facts

Study ID

NCT00319553

Run by

Sanofi

People needed

647

Starts

2006-05-01

Expected to finish

2008-12-01

Last updated by the study team

2012-10-05

Who can join

Age: 11 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 11 - 18 years of age at the time of vaccination in this trial
• Signed Institutional Review Board (IRB)-approved informed assent / consent form.
• Able to attend all scheduled visits and to comply with all trial procedures.
• For a female, negative serum/urine pregnancy test.

You may not qualify if…

• Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
• Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) that is unstable or that might:
• interfere with the ability to participate fully in the study; or
• interfere with evaluation of the vaccine.
• Known or suspected impairment of immunologic function.
• Febrile illness within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of inclusion.
• History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
• Known or suspected receipt of a tetanus or diphtheria-containing vaccine within the preceding 2 years.
• Known or suspected receipt of a pertussis-containing vaccine within the preceding 5 years.
• Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other therapy expected to materially alter immune function within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting less than 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.
• Received any vaccine in the 21-day period prior to enrollment or scheduled to receive any vaccination after enrollment and prior to visit 2.
• Suspected or known hypersensitivity to any of the vaccine components or to latex.

Where it is running

• Study site — Annapolis, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Frederick, Maryland, United States
• Study site — Durham, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Franklin, Tennessee, United States
• Study site — Bellevue, Washington, United States
• Study site — Mercer Island, Washington, United States
• Study site — Sammamish, Washington, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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