Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™

Study Overview
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Brief Summary
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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.

Official Title
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Observational, Ecological, Database Study on Epidemiology of Hospitalisations With Rotavirus Gastroenteritis Confirmed in Children Aged ≤5 Years, and Any Impact in the Change From Lyophilised to Liquid Formulation of Rotarix™, in Belgium

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: Child aged ≤5 years with opportunity to receive lyophilised or liquid formulation of Rotarix™; Hospitalised at one of the participating centres in Belgium; A stool sample has been provided for a rotavirus detection test during the study period; Laboratory test result of rotavirus is available. Exclusion Criteria: • None.

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Children aged <=5 years in Belgium, with opportunity to receive Rotarix, requiring hospitalisation during which rotavirus detection test was performed and with available results. | Other: Data collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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™. | 

Secondary Outcome Measures

| Outcome Measure | 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). |  | 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™. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotarix™, Observational, ecological