Clinical trial NCT00712959: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pertussis
Tetanus
Diphtheria
Keywords: Pertussis
Tetanus
Diphtheria
Acellular pertussis
ADACEL®,
Tdap vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 769
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
timeFrame: Day 0 (pre-vaccination) and 30 post-vaccination
measure: Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose
timeFrame: Day 30 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose
timeFrame: Day 30 post-vaccination
measure: Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose
timeFrame: Day 30 post-vaccination
measure: Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
timeFrame: Day 0 (pre-vaccination) and Day 30 post-vaccination
measure: Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
timeFrame: Day 0 (pre-vaccination) and Day 30 post-vaccination
measure: Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
timeFrame: Day 0 up to Day 7 post-vaccination
Locations:
city: Coquitlam
country: Canada
state: British Columbia
city: Surrey
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Pierrefonds
country: Canada
state: Quebec
city: Québec City
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Halperin SA, Scheifele D, De Serres G, Noya F, Meekison W, Zickler P, Larrivee L, Langley JM, McNeil SA, Dobson S, Jordanov E, Thakur M, Decker MD, Johnson DR. Immune responses in adults to revaccination with a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine 10 years after a previous dose. Vaccine. 2012 Jan 20;30(5):974-82. doi: 10.1016/j.vaccine.2011.11.035. Epub 2011 Nov 21.