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

Completed

• Conditions: Infections, Rotavirus
• Interventions: Other: Data collection

• Registration Number: NCT01435967
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-19
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	Data collection	Children aged \<=5 years in Belgium, with opportunity to receive Rotarix, requiring hospitalisation during which rotavirus detection test was performed and with available results.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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™.

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Yvoir, Belgium