Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose

• Conditions: PertussisTetanusDiphtheria; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005197-38-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-19
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 768

Inclusion Criteria

1) Received Tdap or Tdap-IPV vaccine in study TD9707 or TD9805.
2) Never previously received Tdap vaccine and has not received any tetanus-, diphtheria , or pertussis-containing vaccine in the past 10 years.
3) 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.
4) Signed Institutional Review Board (IRB)-approved informed consent form
5) Able to attend all scheduled visits and to comply with all trial procedures
6) For a woman, a negative urine pregnancy test and the use of effective method(s) of contraception, or the inability to become pregnant
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 758
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1) Any condition listed as a contraindication in the ADACEL® Canadian product monograph
2) 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
3) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
4) 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
5) Febrile illness (temperature = 37.5°C [99.5°F]) at the time of inclusion
6) 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.
7) 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.
8) 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.
9) Receipt of blood or blood-derived products in the past 3 months
10) 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
11) Unable to attend the scheduled visits or to comply with the study procedures
12) In females of childbearing potential, known pregnancy or positive serum/urine pregnancy test
13) Breast-feeding woman
14) 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
15) Current alcohol or recreational drug use that may interfere with the subject's ability to comply with trial procedures
16) Thrombocytopenia, bleeding disorder, anticoagulation therapy contraindicating intramuscular (IM) vaccination
17) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
18) Other events which in the judgment of the investigator would preclude vaccination at the time of Visit 1 For Group 3
19) History of documented diphtheria, pertussis, or tetanus disease since participation in study TD9707 or TD9805
20) Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine since participation in study TD9707 or TD9805.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.;Secondary Objective: Not applicable;Primary end point(s): 1) Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose<br>2) Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose;Timepoint(s) of evaluation of this end point: 1) Day 0 (pre-vaccination) and 30 post-vaccination<br>2) Day 30 post-vaccination