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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diphtheria; Tetanus; Pertussis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712959

TD526

Details and patient eligibility

About

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.

Full 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.

Enrollment: 769 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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769 participants in 3 patient groups

Group 1: Previous Tdap or Tdap-IPV Recipients

Experimental group

Description:

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

Treatment:

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

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

Group 2: Tdap vaccine-naïve

Active Comparator group

Description:

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.

Treatment:

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

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

Group 3

No Intervention group

Description:

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