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| Name | Class |
|---|---|
| Wroclaw Medical University | OTHER |
| Poznan University of Medical Sciences | OTHER |
| Medical University of Silesia | OTHER |
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Assessment of the immunogenicity and safety of booster immunization against diphtheria in children with inflammatory bowel disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diphtheria booster vaccination | Experimental | One booster dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphtheria booster vaccination | Biological | Participants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis |
| Measure | Description | Time Frame |
|---|---|---|
| Achieving seroprotective antibody concentration | Antibody concentrations ≥0.1 IU/ml indicated protection against diphtheria, while levels ≥1.0 IU/ml were considered to ensure long-term protection. | after 4-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Booster response | Booster response was defined as a post-vaccination antibody concentration ≥0.4 IU/mL in initially seronegative subjects or as a fourfold increase of antibody concentration in initially seropositive ones. | after 4-8 weeks |
| Adverse effects |
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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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32032309 | Derived | Dembinski L, Krzesiek E, Klincewicz B, Grzybowska-Chlebowczyk U, Demkow U, Banaszkiewicz A, Radzikowski A. Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease. Pediatr Infect Dis J. 2020 Mar;39(3):244-246. doi: 10.1097/INF.0000000000002547. |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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Evaluation of adverse effects after vaccination. |
| 3 days |
| 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. | after 4-8 weeks |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |