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| Name | Class |
|---|---|
| Medical University of Gdansk | OTHER |
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Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholera vaccination | Experimental | Two doses of the vaccine against cholera |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccination against cholera | Biological | Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achieving seroprotective antibody concentration | Serum antibody concentration indicating protection against cholera. | 4-6 weeks after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | Evaluation of adverse effects after vaccination. | 3 days after each dose |
| Inflammatory bowel disease exacerbation occurrence. | Disease exacerbation assessed according to the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Banaszkiewicz, MD, PhD | Medical University of Warsaw | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw | Warsaw | 02-091 | Poland |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| 4-6 weeks after the second dose |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |