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

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ClinicalTrials.gov Identifier: NCT00712959
Recruitment Status : Completed
First Posted : July 10, 2008
Results First Posted : April 30, 2014
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE July 7, 2008
First Posted Date  ICMJE July 10, 2008
Results First Submitted Date  ICMJE February 18, 2014
Results First Posted Date  ICMJE April 30, 2014
Last Update Posted Date April 30, 2014
Study Start Date  ICMJE June 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2014)
  • Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose [ Time Frame: Day 0 (pre-vaccination) and 30 post-vaccination ]
    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.
  • Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose [ Time Frame: Day 30 post-vaccination ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2008)
Immunogenicity: To provide information concerning immune response to Tdap after booster vaccination. [ Time Frame: 1 month post-vaccination ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 1, 2014)
  • Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose [ Time Frame: Day 30 post-vaccination ]
    Anti-diphtheria or anti-tetanus booster responses were defined as: Pre-vaccination antibody concentrations of < 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response.
  • Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose [ Time Frame: Day 30 post-vaccination ]
    Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:
    • ≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was < LLOQ; or
    • ≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but < 4 x LLOQ; or
    • ≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ.
  • Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]
    Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
  • Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]
    Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).
  • Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: > 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pertussis
  • Tetanus
  • Diphtheria
Intervention  ICMJE
  • Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
    0.5 ml, IM
    Other Names:
    • Tdap
    • ADACEL®
  • Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
    0.5 mL, IM
    Other Names:
    • Tdap
    • Adacel®
Study Arms  ICMJE
  • Experimental: Group 1: Previous Tdap or Tdap-IPV Recipients
    Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
    Intervention: Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
  • Active Comparator: Group 2: Tdap vaccine-naïve
    Participants 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.
    Intervention: Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
  • No Intervention: Group 3
    Past 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
Publications * Halperin SA, Scheifele D, De Serres G, Noya F, Meekison W, Zickler P, Larrivée 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2011)
769
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2008)
900
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00712959
Other Study ID Numbers  ICMJE TD526
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP