Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diphtheria; Pertussis; Tetanus

Treatments: Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00347958

TD518

Details and patient eligibility

About

Objectives:

To provide safety data on revaccination with ADACEL® vaccine.

To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.

Enrollment: 545 patients

Sex: All

Ages: 15 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Previously received ADACEL vaccine as part of Aventis Pasteur studies Td501, Td502, or Td505.
• At least 15 but no greater than 69 years of age at the time of vaccination in this trial.
• Signed Institutional Review Board (IRB)-approved informed assent / consent form.
• Able to attend all scheduled visits and to comply with all trial procedures.
• For a woman, inability to become pregnant or negative serum/urine pregnancy test.

Exclusion criteria

• Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.

• Serious chronic disease (ie, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that might:

  • interfere with the ability to participate fully in the study; or
  • interfere with evaluation of the vaccine.

• Known or suspected impairment of immunologic function.

• Febrile illness within the last 72 hours or an oral temperature ≥100.4°F (≥38°C) at the time of inclusion.

• History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.

• Known or suspected receipt of a tetanus-, diphtheria- or pertussis-containing vaccine since participation in Study Td501, Td502, or Td505. (Receipt of Menactra vaccine at any time prior to the present study is permitted, subject to the next exclusion criterion).

• Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 28-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment

• Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. 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 one course within the last two weeks prior to enrollment.

• Suspected or known hypersensitivity to any of the vaccine components or to latex.

• Unable to attend the scheduled visits or to comply with the study procedures.

• In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment.

• Nursing mother.

• Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.

• Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial visits or procedures.

• Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

• Subject deprived of freedom by an administrative or court order, or under the stress of an emergency setting, or hospitalized without his/her consent.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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545 participants in 1 patient group

Adacel vaccine group

Experimental group

Description:

Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.

Treatment:

Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine