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This study aims to confirm the statistically significant decline in rotavirus related and in acute gastro-enteritis (AGE) related hospital admissions that was observed in 11 participating hospitals, after the introduction of RV vaccines in Belgium in 2006.
This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2010 until the 31st of May 2011. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | All children ≤ 5 years old with a rotavirus detection test (inpatient and ambulatory tests) performed during the period of June the 1st 2010 and May the 31st 2011. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Each participating centre will be requested to generate a coded list of all stool samples taken during the study period (June 1st 2010- May 31st 2011) and analysed for rotavirus, in children aged ≤5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute number of rotavirus related hospitalisations in children up to five years old. | During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of rotavirus positive tests on the total number of rota detection tests | Total number of rota detection tests and number of rotavirus positive tests of the study year will be determined by age-group of 1-year, gender, time of the event, vaccine coverage status. | During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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Children aged ≤5 years undergoing a RV detection test across 11 participating hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33025558 | Derived | Standaert B, Strens D, Pereira P, Benninghoff B, Raes M. Lessons Learned from Long-Term Assessment of Rotavirus Vaccination in a High-Income Country: The Case of the Rotavirus Vaccine Belgium Impact Study (RotaBIS). Infect Dis Ther. 2020 Dec;9(4):967-980. doi: 10.1007/s40121-020-00345-y. Epub 2020 Oct 6. |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| The duration of rota-related hospitalisation for community acquired and nosocomial infection. | During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year) |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |