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OpenTrials
Completed

NCT Number: NCT00524732

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

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).

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Key information

Age range

7 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tetanus and diphtheria toxoids and acellular pertussis

Biological

0.5 mL, Intramuscular

Other names: ADACEL®

Primary outcomes

  1. To provide safety information on ADACEL® vaccine given at different time intervals.

    Time frame: Up to 114 months post-vaccination

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Important dates

Study start
2004
Primary completion
2004
Study completion
2005
First posted
Sep 5, 2007
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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