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The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis. This is planned to be assessed by comparing trends of hospitalisations due to laboratory confirmed rotavirus gastroenteritis in children <=5 years of age, before and after introduction of the liquid formulation of the vaccine in Belgium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Children aged <=5 years in Belgium, with opportunity to receive Rotarix, requiring hospitalisation during which rotavirus detection test was performed and with available results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Data collected when only the lyophilised formulation of Rotarix was in use (which is considered as baseline) will be specifically compared to data collected post the introduction of the liquid formulation. The results will also be compared to available vaccine coverage data for those rotavirus vaccines being used in Belgium. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™ | up to 2 years post-introduction of liquid formulation of Rotarix™. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region). | up to 2 years post-introduction of liquid formulation of Rotarix™. | |
| Occurrence of rotavirus detected by laboratory tests at a specific time (month and year). |
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Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
Exclusion Criteria:
• None.
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Children hospitalised due to laboratory confirmed rotavirus gastroenteritis in approximately 8 hospitals across Belgium.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Antwerp | 2020 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27373141 | Derived | Raes M, Strens D, Kleintjens J, Biundo E, Morel T, Vyse A. Epidemiological trends for hospital admissions for acute rotavirus gastroenteritis in Belgium following the introduction of routine rotavirus vaccination and the subsequent switch from lyophilized to liquid formulation of Rotarix. Epidemiol Infect. 2016 Oct;144(14):3017-3024. doi: 10.1017/S0950268816001151. Epub 2016 Jul 4. |
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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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|
| up to 2 years post-introduction of liquid formulation of Rotarix™. |
| Occurrence of rotavirus detected by various types of rotavirus laboratory tests. | up to 2 years post-introduction of liquid formulation of Rotarix™. |
| Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population. | up to 2 years post-introduction of liquid formulation of Rotarix™. |
| Bonheiden |
| 2820 |
| Belgium |
| GSK Investigational Site | Charleroi | 6000 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Hasselt | 3500 | Belgium |
| GSK Investigational Site | Ieper | 8900 | Belgium |
| GSK Investigational Site | Jette | 1090 | Belgium |
| GSK Investigational Site | Yvoir | 5330 | Belgium |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |