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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Rotavirus

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01435967

114061

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1 participants in 1 patient group

Cohort A

Description:

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

Treatment:

Other: Data collection