Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
- Conditions
- DiphtheriaPertussis
- Interventions
- Biological: Tetanus and diphtheria toxoids and acellular pertussis
- Registration Number
- NCT00524732
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7156
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 7 Tetanus and diphtheria toxoids and acellular pertussis 90 to 102 months since last prior dose of TD/Td vaccine. 8 Tetanus and diphtheria toxoids and acellular pertussis 102 to 114 months since last prior dose of TD/Td vaccine. 5 Tetanus and diphtheria toxoids and acellular pertussis 66 to 78 months since last prior dose of TD/Td vaccine. 2 Tetanus and diphtheria toxoids and acellular pertussis 30 to 42 months since last prior dose of TD/Td vaccine. 6 Tetanus and diphtheria toxoids and acellular pertussis 78 to 90 months since last prior dose of TD/Td vaccine. 1 Tetanus and diphtheria toxoids and acellular pertussis 18 to 30 months since last prior dose of TD/Td vaccine. 4 Tetanus and diphtheria toxoids and acellular pertussis 54 to 66 months since last prior dose of TD/Td vaccine. 3 Tetanus and diphtheria toxoids and acellular pertussis 42 to 54 months since last prior dose of TD/Td vaccine. 9 Tetanus and diphtheria toxoids and acellular pertussis Control - over 114 months since last prior dose of TD/Td vaccine.
- Primary Outcome Measures
Name Time Method To provide safety information on ADACEL® vaccine given at different time intervals. Up to 114 months post-vaccination
- Secondary Outcome Measures
Name Time Method