Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age

January 10, 2014 updated by: Sanofi Pasteur, a Sanofi Company
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Charlottetown, Canada, C1A 7N8
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, NS B3K 6R8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other Names:
  • ADACEL®
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
Other Names:
  • ADACEL®
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
Other Names:
  • ADACEL®
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
Other Names:
  • ADACEL®
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
Other Names:
  • ADACEL®
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
Other Names:
  • ADACEL®
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
Other Names:
  • ADACEL®
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
Other Names:
  • ADACEL®
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
Other Names:
  • ADACEL®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide safety information on ADACEL® vaccine given at different time intervals.
Time Frame: Up to 114 months post-vaccination
Up to 114 months post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 4, 2007

First Posted (Estimate)

September 5, 2007

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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