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To compare the reactogenicity of ADACELĀ® vaccine given at intervals of 2 to 9 years with the reactogenicity of ADACELĀ® 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | 18 to 30 months since last prior dose of TD/Td vaccine. |
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| 2 | 30 to 42 months since last prior dose of TD/Td vaccine. |
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| 3 | 42 to 54 months since last prior dose of TD/Td vaccine. |
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| 4 | 54 to 66 months since last prior dose of TD/Td vaccine. |
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| 5 | 66 to 78 months since last prior dose of TD/Td vaccine. |
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| 6 | 78 to 90 months since last prior dose of TD/Td vaccine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus and diphtheria toxoids and acellular pertussis | Biological | 0.5 mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| To provide safety information on ADACELĀ® vaccine given at different time intervals. | Up to 114 months post-vaccination |
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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.
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Children and Adolescents 7 to 19 Years of Age, who have previously recieved Tetanus and Diphtheria Toxoids Vaccine
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Halifax | Nova Scotia | NS B3K 6R8 | Canada | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16511379 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| C509326 | adacel |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 7 | 90 to 102 months since last prior dose of TD/Td vaccine. |
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| 8 | 102 to 114 months since last prior dose of TD/Td vaccine. |
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| 9 | Control - over 114 months since last prior dose of TD/Td vaccine. |
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| Charlottetown |
| C1A 7N8 |
| Canada |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D003015 | Clostridium Infections |