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

GlaxoSmithKline1 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Infections, Rotavirus

Interventions

Data collectionOTHER

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.

Eligibility

Sex: ALLMax age: 5 Years

Medical Language ↔ Plain English

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.

Locations (8)

GSK Investigational Site

Antwerp, Belgium

GSK Investigational Site

Bonheiden, Belgium

GSK Investigational Site

Charleroi, Belgium

GSK Investigational Site

Ghent, Belgium

Outcomes

Primary Outcomes

Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™