Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

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.
 
ClinicalTrials.gov Identifier: NCT00319553
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : October 21, 2010
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE April 28, 2006
First Posted Date  ICMJE April 27, 2006
Results First Submitted Date  ICMJE September 28, 2010
Results First Posted Date  ICMJE October 21, 2010
Last Update Posted Date October 5, 2012
Study Start Date  ICMJE May 2006
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2012)
  • Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® [ Time Frame: Day 0 to 7 post-vaccination ]
    Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities.
  • Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. [ Time Frame: Day 0 and 28 days post-vaccination ]
  • Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. [ Time Frame: Day 0 and 28 days post-vaccination ]
  • Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. [ Time Frame: Day 0 and 28 days post-vaccination ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00319553 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 Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
Official Title  ICMJE Comparison in US Adolescents of the Safety and Immunogenicity of Two Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccines: ADACEL™ and BOOSTRIX®
Brief Summary This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pertussis
  • Tetanus
  • Diphtheria
Intervention  ICMJE
  • Biological: ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
    0.5 mL, IM
    Other Name: ADACEL®
  • Biological: BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
    0.5 mL, IM
    Other Name: BOOSTRIX®
Study Arms  ICMJE
  • Experimental: Adacel® Vaccine Group
    Intervention: Biological: ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
  • Active Comparator: BOOSTRIX® Vaccine Group
    Intervention: Biological: BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
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: September 28, 2012)
647
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 11 - 18 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 female, 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 (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) 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 or diphtheria-containing vaccine within the preceding 2 years.
  • Known or suspected receipt of a pertussis-containing vaccine within the preceding 5 years.
  • Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other therapy expected to materially alter immune function 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.
  • Received any vaccine in the 21-day period prior to enrollment or scheduled to receive any vaccination after enrollment and prior to visit 2.
  • Suspected or known hypersensitivity to any of the vaccine components or to latex.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00319553
Other Study ID Numbers  ICMJE Td516
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date September 2012

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