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

Study Overview
=================
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).

Conditions
-----------------
Pertussis, Diphtheria

Intervention / Treatment
-----------------
* Biological: Tetanus and diphtheria toxoids and acellular pertussis


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>18 to 30 months since last prior dose of TD/Td vaccine. | Biological: Tetanus and diphtheria toxoids and acellular pertussis<br>* 0.5 mL, Intramuscular<br>* Other names: ADACEL®;|
| 2<br>30 to 42 months since last prior dose of TD/Td vaccine. | Biological: Tetanus and diphtheria toxoids and acellular pertussis<br>* 0.5 mL, Intramuscular<br>* Other names: ADACEL®;|
| 3<br>42 to 54 months since last prior dose of TD/Td vaccine. | Biological: Tetanus and diphtheria toxoids and acellular pertussis<br>* 0.5 mL, Intramuscular<br>* Other names: ADACEL®;|
| 4<br>54 to 66 months since last prior dose of TD/Td vaccine. | Biological: Tetanus and diphtheria toxoids and acellular pertussis<br>* 0.5 mL, Intramuscular<br>* Other names: ADACEL®;|
| 5<br>66 to 78 months since last prior dose of TD/Td vaccine. | Biological: Tetanus and diphtheria toxoids and acellular pertussis<br>* 0.5 mL, Intramuscular<br>* Other names: ADACEL®;|
| 6<br>78 to 90 months since last prior dose of TD/Td vaccine. | Biological: Tetanus and diphtheria toxoids and acellular pertussis<br>* 0.5 mL, Intramuscular<br>* Other names: ADACEL®;|
| 7<br>90 to 102 months since last prior dose of TD/Td vaccine. | Biological: Tetanus and diphtheria toxoids and acellular pertussis<br>* 0.5 mL, Intramuscular<br>* Other names: ADACEL®;|
| 8<br>102 to 114 months since last prior dose of TD/Td vaccine. | Biological: Tetanus and diphtheria toxoids and acellular pertussis<br>* 0.5 mL, Intramuscular<br>* Other names: ADACEL®;|
| 9<br>Control - over 114 months since last prior dose of TD/Td vaccine. | Biological: Tetanus and diphtheria toxoids and acellular pertussis<br>* 0.5 mL, Intramuscular<br>* Other names: ADACEL®;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pertussis, Tetanus, Diphtheria