Status:
COMPLETED
Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Pertussis
Tetanus
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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...
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 vacci...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
769 Patients enrolled
Trial Details
Trial ID
NCT00712959
Start Date
June 1 2008
End Date
December 1 2009
Last Update
April 30 2014
Active Locations (7)
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1
Coquitlam, British Columbia, Canada, V3C 4J2
2
Surrey, British Columbia, Canada, V3R 8P8
3
Vancouver, British Columbia, Canada, V6H 3V4
4
Halifax, Nova Scotia, Canada, B3K 6R8