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Trial record 1 of 1 for:    TD511
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Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age

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ClinicalTrials.gov Identifier: NCT00524732
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date September 4, 2007
First Posted Date September 5, 2007
Last Update Posted Date January 14, 2014
Study Start Date September 2004
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2008)
To provide safety information on ADACEL® vaccine given at different time intervals. [ Time Frame: Up to 114 months post-vaccination ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
Official Title Not Provided
Brief Summary To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last previous administration of vaccine containing Diphtheria and Tetanus Toxoids (referred to as TD/Td).
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children and Adolescents 7 to 19 Years of Age, who have previously recieved Tetanus and Diphtheria Toxoids Vaccine
Condition
  • Pertussis
  • Diphtheria
Intervention Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Name: ADACEL®
Study Groups/Cohorts
  • 1
    18 to 30 months since last prior dose of TD/Td vaccine.
    Intervention: Biological: Tetanus and diphtheria toxoids and acellular pertussis
  • 2
    30 to 42 months since last prior dose of TD/Td vaccine.
    Intervention: Biological: Tetanus and diphtheria toxoids and acellular pertussis
  • 3
    42 to 54 months since last prior dose of TD/Td vaccine.
    Intervention: Biological: Tetanus and diphtheria toxoids and acellular pertussis
  • 4
    54 to 66 months since last prior dose of TD/Td vaccine.
    Intervention: Biological: Tetanus and diphtheria toxoids and acellular pertussis
  • 5
    66 to 78 months since last prior dose of TD/Td vaccine.
    Intervention: Biological: Tetanus and diphtheria toxoids and acellular pertussis
  • 6
    78 to 90 months since last prior dose of TD/Td vaccine.
    Intervention: Biological: Tetanus and diphtheria toxoids and acellular pertussis
  • 7
    90 to 102 months since last prior dose of TD/Td vaccine.
    Intervention: Biological: Tetanus and diphtheria toxoids and acellular pertussis
  • 8
    102 to 114 months since last prior dose of TD/Td vaccine.
    Intervention: Biological: Tetanus and diphtheria toxoids and acellular pertussis
  • 9
    Control - over 114 months since last prior dose of TD/Td vaccine.
    Intervention: Biological: Tetanus and diphtheria toxoids and acellular pertussis
Publications * Halperin SA, Sweet L, Baxendale D, Neatby A, Rykers P, Smith B, Zelman M, Maus D, Lavigne P, Decker MD. How soon after a prior tetanus-diphtheria vaccination can one give adult formulation tetanus-diphtheria-acellular pertussis vaccine? Pediatr Infect Dis J. 2006 Mar;25(3):195-200.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 13, 2008)
7156
Original Enrollment Not Provided
Actual Study Completion Date September 2005
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age > 7 years and < 20 years.
  • Signed and dated IRB-approved informed consent form obtained from the participant, parent or legal guardian prior to the first study intervention.
  • Judged to be in good health on the basis of reported medical history.
  • Available for planned length of the study.
  • Participant or parent or legal guardian (as applicable) can read and write English and can understand the informed consent documents and the study instructions.

A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).

A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.

Exclusion Criteria:

  • Known or suspected allergy to ADACEL®, any of the vaccine's components, or prior allergic reaction to Diphtheria or Tetanus Toxoids or Acellular Pertussis Vaccine.
  • Planned receipt of any other vaccine within the 14 days following administration of ADACEL® vaccine in this study.
  • Any other medical condition that in the opinion of the investigator would cause an unexpected hazard or interfere with the study objective.
  • Receipt of TD/Td within the preceding 12 months.
  • Known or suspected to be pregnant.

A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).

A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.

Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00524732
Other Study ID Numbers TD511
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor Sanofi Pasteur, a Sanofi Company
Collaborators Not Provided
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date January 2014