Brief Title
Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
Official Title
Immune Responses in Adults to Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose
Brief Summary
The purpose of this study is to collect additional immunogenicity and safety data on
re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health
need to establish broader population immunity against pertussis, as well as diphtheria and
tetanus.
Primary Objective:
- To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.
Detailed Description
This is an open-label, multicenter study to describe the immunological response and safety of
repeat administration of an adolescent/adult-formulation tetanus-diphtheria-acellular
pertussis Tdap vaccine (ADACEL®), 10 years following initial administration of Tdap vaccine.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
Condition
Pertussis
Intervention
Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
Study Arms / Comparison Groups
Group 1: Previous Tdap or Tdap-IPV Recipients
Description: Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
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
769
Start Date
June 2008
Completion Date
December 2009
Primary Completion Date
September 2009
Eligibility Criteria
Inclusion Criteria :
- Received Tdap or Tdap-IPV vaccine in study TD9707 or TD9805.
- Never previously received Tdap vaccine and has not received any tetanus-, diphtheria ,
or pertussis-containing vaccine in the past 10 years.
- Participated in TD9707 or TD9805 but does not meet inclusion/ exclusion criteria or
willing to undergo phlebotomy but not willing to receive Tdap (ADACEL®) vaccine.
- Signed Institutional Review Board (IRB)-approved informed consent form
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, a negative urine pregnancy test and the use of effective method(s) of
contraception, or the inability to become pregnant
Exclusion Criteria :
- Any condition listed as a contraindication in the ADACEL® Canadian product monograph
- 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
- Chronic illness, at a stage that could interfere with trial conduct or completion, in
the opinion of the investigator
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
or long-term systemic (injected or oral) corticosteroid therapy. 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 1 course within the last 2 weeks
prior to enrollment
- Febrile illness (temperature ≥ 37.5°C [99.5°F]) at the time of inclusion
- History of documented diphtheria, pertussis, or tetanus disease since participation in
studies TD9707 or TD9805. Or history of documented diphtheria, pertussis, or tetanus
disease in the last 10 years.
- Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine
since participation in study TD9707 or TD9805. For Group 2, known or suspected receipt
of a diphtheria-, pertussis-, or tetanus-containing vaccine in the last 10 years.
- Receipt of any vaccine, other than influenza vaccine, in the 28-day period prior to
Visit 1 or scheduled to receive any vaccine, other than influenza vaccine, in the
period between Visit 1 and Visit 2. For influenza vaccine only, defer if received in
the 14 days prior to enrollment or scheduled to receive prior to Visit 2.
- Receipt of blood or blood-derived products in the past 3 months
- Suspected or known hypersensitivity to any of the vaccine components, or a
life-threatening reaction after previous administration of the vaccine or a vaccine
containing the same substances
- Unable to attend the scheduled visits or to comply with the study procedures
- In females of childbearing potential, known pregnancy or positive serum/urine
pregnancy test
- Breast-feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device,
or a medical procedure in the 4 weeks preceding enrollment. Planned participation in
another clinical trial during the present trial period
- Current alcohol or recreational drug use that may interfere with the subject's ability
to comply with trial procedures
- Thrombocytopenia, bleeding disorder, anticoagulation therapy contraindicating
intramuscular (IM) vaccination
- Subject deprived of freedom by an administrative or court order, or in an emergency
setting, or hospitalized without his/her consent.
- Other events which in the judgment of the investigator would preclude vaccination at
the time of Visit 1 For Group 3
- History of documented diphtheria, pertussis, or tetanus disease since participation in
study TD9707 or TD9805
- Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine
since participation in study TD9707 or TD9805.
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00712959
Organization ID
TD526
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
April 2014