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

March 6, 2015 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
        • GSK Investigational Site
      • Bonheiden, Belgium, 2820
        • GSK Investigational Site
      • Charleroi, Belgium, 6000
        • GSK Investigational Site
      • Gent, Belgium, 9000
        • GSK Investigational Site
      • Hasselt, Belgium, 3500
        • GSK Investigational Site
      • Ieper, Belgium, 8900
        • GSK Investigational Site
      • Jette, Belgium, 1090
        • GSK Investigational Site
      • Yvoir, Belgium, 5330
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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™.
up to 2 years post-introduction of liquid formulation of Rotarix™.

Secondary Outcome Measures

Outcome Measure
Time Frame
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™.
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).
Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™.
up to 2 years post-introduction of liquid formulation of Rotarix™.
Occurrence of rotavirus detected by various types of rotavirus laboratory tests.
Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™.
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.
Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™.
up to 2 years post-introduction of liquid formulation of Rotarix™.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 9, 2011

First Submitted That Met QC Criteria

September 15, 2011

First Posted (Estimate)

September 19, 2011

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 6, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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