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Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00524732
  Purpose

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).


Condition Intervention
Pertussis
Diphtheria
Biological: Tetanus and diphtheria toxoids and acellular pertussis

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough
Drug Information available for: Diphtheria-Pertussis-Tetanus Vaccine
U.S. FDA Resources
Study Type: Observational
Study Design: Cross-Sectional

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide safety information on ADACEL® vaccine given at different time intervals. [ Time Frame: Up to 114 months post-vaccination ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 7156
Study Start Date: September 2004
Study Completion Date: September 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
18 to 30 months since last prior dose of TD/Td vaccine.
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
2
30 to 42 months since last prior dose of TD/Td vaccine.
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
3
42 to 54 months since last prior dose of TD/Td vaccine.
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
4
54 to 66 months since last prior dose of TD/Td vaccine.
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
5
66 to 78 months since last prior dose of TD/Td vaccine.
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
6
78 to 90 months since last prior dose of TD/Td vaccine.
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
7
90 to 102 months since last prior dose of TD/Td vaccine.
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
8
102 to 114 months since last prior dose of TD/Td vaccine.
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
9
Control - over 114 months since last prior dose of TD/Td vaccine.
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular

  Eligibility

Ages Eligible for Study:   7 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524732

Locations
Canada
Charlottetown, Canada, C1A 7N8
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, NS B3K 6R8
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: Sanofi Pasteur Inc ( Medical Monitor )
Study ID Numbers: TD511
Study First Received: September 4, 2007
Last Updated: October 13, 2008
ClinicalTrials.gov Identifier: NCT00524732  
Health Authority: Canada: Health Canada

Keywords provided by Sanofi-Aventis:
Pertussis
Tetanus
Diphtheria

Study placed in the following topic categories:
Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Cough
Whooping Cough
Diphtheria
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:
Bordetella Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 14, 2009