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Trial record 1 of 1 for:    TD518
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Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347958
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : July 22, 2010
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Tetanus Diphtheria Pertussis Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 545 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety Among Adolescents and Adults of Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) 4 to 5 Years After a Previous Dose
Study Start Date : August 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: Adacel vaccine group
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.
Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
0.5mL, Intramuscular (IM)
Other Name: Adacel®

Primary Outcome Measures :
  1. Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination [ Time Frame: 0-14 days post-vaccination ]
    Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.

Other Outcome Measures:
  1. Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination. [ Time Frame: Day 28 post-vaccination ]
    Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralization testing; the other antibody levels were determined by enzyme-linked immunosorbent assay testing.

  2. Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination. [ Time Frame: Day 28 post-vaccination ]
    Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.

  3. Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel® [ Time Frame: Day 28 post-vaccination ]
    Seroprotection: Tetanus or diphtheria titer ≥ 0.1 after Adacel® vaccination. Tetanus titers determined by enzyme-linked immunosorbent assay; diphtheria titers determined by toxin neutralization assay.

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Ages Eligible for Study:   15 Years to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347958

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United States, Arkansas
Jonesboro, Arkansas, United States, 72401
United States, Louisiana
Bossier City, Louisiana, United States, 71111
United States, Ohio
University Heights, Ohio, United States, 44118
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
Canada, British Columbia
Coquitlam, British Columbia, Canada, V3C 4J2
Surrey, British Columbia, Canada, V3R-8P8
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3K-6R8
Canada, Quebec
Beauport, Quebec, Canada, G1E 7G9
Montreal, Quebec, Canada, H3H LP3
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
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Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT00347958    
Other Study ID Numbers: TD518
First Posted: July 4, 2006    Key Record Dates
Results First Posted: July 22, 2010
Last Update Posted: December 4, 2013
Last Verified: November 2013
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Additional relevant MeSH terms:
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Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Corynebacterium Infections
Actinomycetales Infections