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Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
This study is enrolling participants by invitation only.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00712959
  Purpose

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.

Condition Intervention Phase
Pertussis
Tetanus
Diphtheria
Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
Phase IV

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough
Drug Information available for: Diphtheria-Pertussis-Tetanus Vaccine Tetanus Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Immunogenicity: To provide information concerning immune response to Tdap after booster vaccination. [ Time Frame: 1 month post vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: June 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Received Tdap or Tdap-IPV in a previous study
Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
0.5 ml, IM
2: Active Comparator
Tdap-naïve but a previous tetanus, diphtheria and/or pertussis dose.
Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
0.5 mL, IM
3: No Intervention

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712959

Locations
Canada, British Columbia
Coquitlam, British Columbia, Canada, V3C 4J2
Vancouver, British Columbia, Canada, V6H 3V4
Surrey, British Columbia, Canada, V3R 8P8
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Quebec
Pierrefonds, Quebec, Canada, H9H 4Y6
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Emilia Jordanov, MD Sanofi Pasteur Inc.
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: TD526
Study First Received: July 7, 2008
Last Updated: July 9, 2008
ClinicalTrials.gov Identifier: NCT00712959  
Health Authority: Canada: Health Canada

Keywords provided by Sanofi-Aventis:
Pertussis
Tetanus
Diphtheria
Acellular pertussis
ADACEL®,
Tdap vaccine

Study placed in the following topic categories:
Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Cough
Whooping Cough
Diphtheria
Clostridium Infections
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:
Bordetella Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 14, 2009