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

Infections, Rotavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435967
• Other study ID #: 114061
• Status: Completed
• Phase: N/A
• First received: September 9, 2011
• Last updated: March 6, 2015
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Agence Fédérale des Medicaments et des Produits de la Santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Gastroenteritis
• Infections, Rotavirus
• Rotavirus Infections

Intervention

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.

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Bonheiden
Belgium	GSK Investigational Site	Charleroi
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Hasselt
Belgium	GSK Investigational Site	Ieper
Belgium	GSK Investigational Site	Jette
Belgium	GSK Investigational Site	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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™.	No
Secondary	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™.	No
Secondary	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™.	No
Secondary	Occurrence of rotavirus detected by various types of rotavirus laboratory tests.		up to 2 years post-introduction of liquid formulation of Rotarix™.	No
Secondary	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™.	No