NCT01435967

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
OTHER	Data collection	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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2011-09-19
• Last updated: 2015-03-09

Locations

8 sites across 1 country: Belgium