Brief Title
A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older
Official Title
Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) in Persons ≥65 Years of Age
Brief Summary
It is well recognized that older adults can contract pertussis, suffer its complications, and
unwittingly transmit it to close contacts, which may well include infants too young to have
received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in
the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for
administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no
upper limit on its age indication.
The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine
among individuals ≥ 65 years of age.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Condition
Pertussis
Intervention
ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Study Arms / Comparison Groups
Adacel Vaccine Group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
1564
Start Date
March 2007
Completion Date
November 2008
Primary Completion Date
September 2008
Eligibility Criteria
Inclusion Criteria :
- Ambulatory and not institutionalized.
- 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 :
- 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 (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.
Gender
All
Ages
65 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00457249
Organization ID
TD515
Responsible Party
Sponsor
Study Sponsor
Sanofi
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
September 2012