Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
NCT ID: NCT00524732
Last Updated: 2014-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
7156 participants
OBSERVATIONAL
2004-09-30
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CROSS_SECTIONAL
Study Groups
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1
18 to 30 months since last prior dose of TD/Td vaccine.
Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
2
30 to 42 months since last prior dose of TD/Td vaccine.
Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
3
42 to 54 months since last prior dose of TD/Td vaccine.
Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
4
54 to 66 months since last prior dose of TD/Td vaccine.
Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
5
66 to 78 months since last prior dose of TD/Td vaccine.
Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
6
78 to 90 months since last prior dose of TD/Td vaccine.
Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
7
90 to 102 months since last prior dose of TD/Td vaccine.
Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
8
102 to 114 months since last prior dose of TD/Td vaccine.
Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
9
Control - over 114 months since last prior dose of TD/Td vaccine.
Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Interventions
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Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
7 Years
19 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Halifax, Nova Scotia, Canada
Charlottetown, , Canada
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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TD511
Identifier Type: -
Identifier Source: org_study_id
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