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

Diphtheria Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524732
• Other study ID #: TD511
• Status: Completed
• Phase: N/A
• First received: September 4, 2007
• Last updated: January 10, 2014
• Start date: September 2004
• Est. completion date: September 2005

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7156
• Est. completion date: September 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 19 Years

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diphtheria
• Pertussis

Intervention

Biological:
• Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide safety information on ADACEL® vaccine given at different time intervals.		Up to 114 months post-vaccination	Yes

External Links

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