Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
1 other identifier
interventional
769
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2008
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
July 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
April 30, 2014
CompletedApril 30, 2014
April 1, 2014
1.3 years
July 7, 2008
February 18, 2014
April 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL.
Day 0 (pre-vaccination) and 30 post-vaccination
Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose
Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Day 30 post-vaccination
Other Outcomes (5)
Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose
Day 30 post-vaccination
Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose
Day 30 post-vaccination
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Day 0 (pre-vaccination) and Day 30 post-vaccination
- +2 more other outcomes
Study Arms (3)
Group 1: Previous Tdap or Tdap-IPV Recipients
EXPERIMENTALParticipants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
Group 2: Tdap vaccine-naïve
ACTIVE COMPARATORParticipants are age-balanced Tdap vaccine-naïve and will receive Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
Group 3
NO INTERVENTIONPast participants in Study TD9707 and TD9805 did not qualify for Tdap re-administration in this study or were unwilling to receive a second dose of Tdap. They were not included in the analysis for the study
Interventions
0.5 ml, IM
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Coquitlam, British Columbia, V3C 4J2, Canada
Unknown Facility
Surrey, British Columbia, V3R 8P8, Canada
Unknown Facility
Vancouver, British Columbia, V6H 3V4, Canada
Unknown Facility
Halifax, Nova Scotia, B3K 6R8, Canada
Unknown Facility
Pierrefonds, Quebec, H9H 4Y6, Canada
Unknown Facility
Québec, Quebec, G1E 7G9, Canada
Unknown Facility
Sherbrooke, Quebec, J1H 4J6, Canada
Related Publications (1)
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.
PMID: 22115634RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2008
First Posted
July 10, 2008
Study Start
June 1, 2008
Primary Completion
September 1, 2009
Study Completion
December 1, 2009
Last Updated
April 30, 2014
Results First Posted
April 30, 2014
Record last verified: 2014-04