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

NCT ID: NCT00712959

Last Updated: 2014-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 769 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Pertussis; Tetanus; Diphtheria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1: Previous Tdap or Tdap-IPV Recipients

Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)

Group Type: EXPERIMENTAL

Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)

Intervention Type: BIOLOGICAL

0.5 ml, IM

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.

Group Type: ACTIVE_COMPARATOR

Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)

Intervention Type: BIOLOGICAL

0.5 mL, IM

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)

0.5 ml, IM

Intervention Type: BIOLOGICAL

Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)

0.5 mL, IM

Intervention Type: BIOLOGICAL

Other Intervention Names

Tdap; ADACEL®; Tdap; Adacel®

Eligibility 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.

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Coquitlam, British Columbia, Canada

Surrey, British Columbia, Canada

Vancouver, British Columbia, Canada

Halifax, Nova Scotia, Canada

Pierrefonds, Quebec, Canada

Québec, Quebec, Canada

Sherbrooke, Quebec, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 22115634 (View on PubMed)

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

TD526

Identifier Type: -

Identifier Source: org_study_id