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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00712959
First received: July 7, 2008
Last updated: April 1, 2014
Last verified: April 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 769
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
0.5 ml, IM
Other Names:
  • Tdap
  • 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.
Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
0.5 mL, IM
Other Names:
  • Tdap
  • 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

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712959

Locations
Canada, British Columbia
Coquitlam, British Columbia, Canada, V3C 4J2
Surrey, British Columbia, Canada, V3R 8P8
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Quebec
Pierrefonds, Quebec, Canada, H9H 4Y6
Québec City, Quebec, Canada, G1E 7G9
Sherbrooke, Quebec, Canada, J1H 4J6
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00712959     History of Changes
Other Study ID Numbers: TD526
Study First Received: July 7, 2008
Results First Received: February 18, 2014
Last Updated: April 1, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014