A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older
NCT ID: NCT00457249
Last Updated: 2012-10-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1564 participants
INTERVENTIONAL
2007-03-31
2008-11-30
Brief Summary
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The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Adacel Vaccine Group
ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
DECAVAC Vaccine Group
DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
0.5 mL, IM
Interventions
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ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
0.5 mL, IM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 65 years of age at the time of vaccination.
* Signed Institutional Review Board (IRB)-approved informed consent form.
* Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
* Serious chronic disease (eg, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that, in the opinion of the investigator, 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, including use of immune suppressive medications (eg, rheumatoid arthritis drugs such as methotrexate; cancer chemotherapy agents such as vincristine).
* Febrile illness within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of inclusion.
* Any history of documented tetanus, diphtheria or pertussis disease.
* Known or suspected receipt of a tetanus, diphtheria or acellular pertussis containing vaccine within the preceding 5 years.
* Administration of immune globulin or other blood products within the last three months, or systemic corticosteroid therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 6 months.
* Systemic antibiotic therapy within the 72 hours prior to enrollment.
* Received any vaccine, other than influenza vaccine, in the 30-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 35-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment.
* Suspected or known hypersensitivity to any of the vaccine components.
* Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
* Use of alcohol or drugs in a manner that may, in the opinion of the investigator, interfere with the subject's ability to comply with trial visits or procedures.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent, or requires a legally authorized representative.
65 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Chandler, Arizona, United States
Phoenix, Arizona, United States
Cypress, California, United States
San Luis Obispo, California, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Rockville, Maryland, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Mogadore, Ohio, United States
Knoxville, Tennessee, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Annandale, Virginia, United States
Williamsburg, Virginia, United States
Countries
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Related Links
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Related Info
Other Identifiers
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TD515
Identifier Type: -
Identifier Source: org_study_id