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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01435967

First received: September 9, 2011

Last updated: January 21, 2013

Last verified: July 2012

History of Changes

Purpose

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.

Condition	Intervention
Rotavirus Gastroenteritis	Other: Data collection

Study Type:	Observational
Study Design:	Observational Model: Ecologic or Community Time Perspective: Retrospective
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

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis

Drug Information available for: Rotarix

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™ [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region). [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
Occurrence of rotavirus detected by laboratory tests at a specific time (month and year). [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
Occurrence of rotavirus detected by various types of rotavirus laboratory tests. [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population. [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]

Estimated Enrollment:	7000
Study Start Date:	October 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cohort A Children aged <=5 years in Belgium, with opportunity to receive Rotarix, requiring hospitalisation during which rotavirus detection test was performed and with available results.	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.

Eligibility

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children hospitalised due to laboratory confirmed rotavirus gastroenteritis in approximately 8 hospitals across Belgium.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435967

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01435967 History of Changes
Other Study ID Numbers:	114061
Study First Received:	September 9, 2011
Last Updated:	January 21, 2013
Health Authority:	Belgium: Agence Fédérale des Medicaments et des Produits de la Santé

Keywords provided by GlaxoSmithKline:

ecological
Observational
Rotarix™

Additional relevant MeSH terms:

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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