Clinical trial NCT00524732: Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertussis
Diphtheria
Keywords: Pertussis
Tetanus
Diphtheria
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-09-05
Enrollment: 7156
Sex: ALL
Minimum age (years): 7
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
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

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).


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.

Primary outcomes:
measure: To provide safety information on ADACEL® vaccine given at different time intervals.
timeFrame: Up to 114 months post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
state: Nova Scotia
city: Charlottetown
country: Canada
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1097/01.inf.0000202082.56403.c4.