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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00524732 |
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).
Condition | Intervention |
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Pertussis Diphtheria |
Biological: Tetanus and diphtheria toxoids and acellular pertussis |
Study Type: | Observational |
Study Design: | Cross-Sectional |
Enrollment: | 7156 |
Study Start Date: | September 2004 |
Study Completion Date: | September 2005 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
18 to 30 months since last prior dose of TD/Td vaccine.
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Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
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2
30 to 42 months since last prior dose of TD/Td vaccine.
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Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
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3
42 to 54 months since last prior dose of TD/Td vaccine.
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Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
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4
54 to 66 months since last prior dose of TD/Td vaccine.
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Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
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5
66 to 78 months since last prior dose of TD/Td vaccine.
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Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
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6
78 to 90 months since last prior dose of TD/Td vaccine.
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Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
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7
90 to 102 months since last prior dose of TD/Td vaccine.
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Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
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8
102 to 114 months since last prior dose of TD/Td vaccine.
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Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
|
9
Control - over 114 months since last prior dose of TD/Td vaccine.
|
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
|
Ages Eligible for Study: | 7 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Children and Adolescents 7 to 19 Years of Age, who have previously recieved Tetanus and Diphtheria Toxoids Vaccine
Inclusion Criteria:
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:
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.
Responsible Party: | Sanofi Pasteur Inc ( Medical Monitor ) |
Study ID Numbers: | TD511 |
Study First Received: | September 4, 2007 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00524732 |
Health Authority: | Canada: Health Canada |
Pertussis Tetanus Diphtheria |
Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Cough |
Whooping Cough Diphtheria Tetanus Whooping cough Gram-Negative Bacterial Infections |
Bordetella Infections Corynebacterium Infections Infection Actinomycetales Infections |