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Primary objective: This is a descriptive study and the primary objective is to determine the incidence of injection site and systemic adverse events after Triaxis administration as a 5th dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children
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| Measure | Description | Time Frame |
|---|---|---|
| All Injection Site and Systemic Adverse Events | 30 days following vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Have been previously vaccinated with a 5th dose of tetanus, diphtheria and pertussis.
Presence of a contra-indication or cautions to vaccination in accordance with the Spanish version of the EU SmPC:
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Children between 4-6 years of age who attend the investigator's office to receive a 5th dose of tetanus, diphtheria and pertussis Triaxis vaccine as part of the routine vaccination schedule, as described in the Spanish version of the EU SmPC and local vaccination calendar
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre 11 | Almería | Spain | ||||
| Centre 12 |
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| Almería |
| Spain |
| Centre 13 | Almería | Spain |
| Centre 14 | Almería | Spain |
| Centre 15 | Almería | Spain |
| Centre 16 | Almería | Spain |
| Centre 17 | Almería | Spain |
| Centre 18 | Almería | Spain |
| Centre 19 | Almería | Spain |
| Centre 20 | Almería | Spain |
| Centre 21 | Almería | Spain |
| Centre 22 | Almería | Spain |
| Centre 10 | Madrid | Spain |
| Centre 1 | Madrid | Spain |
| Centre 2 | Madrid | Spain |
| Centre 3 | Madrid | Spain |
| Centre 4 | Madrid | Spain |
| Centre 5 | Madrid | Spain |
| Centre 6 | Madrid | Spain |
| Centre 7 | Madrid | Spain |
| Centre 8 | Madrid | Spain |
| Centre 9 | Madrid | Spain |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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