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

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ClinicalTrials.gov Identifier: NCT00347958
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : July 22, 2010
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE July 3, 2006
First Posted Date  ICMJE July 4, 2006
Results First Submitted Date  ICMJE May 14, 2010
Results First Posted Date  ICMJE July 22, 2010
Last Update Posted Date December 4, 2013
Study Start Date  ICMJE August 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2010)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00347958 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 11, 2013)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Tetanus
  • Diphtheria
  • Pertussis
Intervention  ICMJE Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
0.5mL, Intramuscular (IM)
Other Name: Adacel®
Study Arms  ICMJE 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.
Intervention: Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2008)
545
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 69 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00347958
Other Study ID Numbers  ICMJE TD518
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP