Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium

January 16, 2017 updated by: GlaxoSmithKline

Epidemiological, Observational, Post Marketing Study of the Genetic Stability of GSK Biologicals' Rotavirus Vaccine (Rotarix™) in Children <5 Years of Age Diagnosed With Severe Gastroenteritis, in Belgium

The main aim of this study is to investigate cases of rotavirus gastroenteritis in Belgian children with opportunity to receive Rotarix™ to monitor the potential occurrence of genetic drifts (point mutations) in the vaccine strain and the occurrence of genetic shifts (re-assortments) between vaccine and naturally circulating wild-type strains in Belgium population after the introduction of Rotarix™. The study will also detect if there is any alteration in rotavirus pathogenicity conferred by re-assortment and if the mutated vaccine strain is still efficacious in preventing rotavirus gastroenteritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is conducted in two phases: Phase I and Phase II. Phase I will be retrospective and consist of re-using the data collected in RotaBel (EPI-ROTA-111426) study. Phase II will be prospective and consist of maintaining the active surveillance system to identify rotavirus cases in several hospitals in Belgium.

Study Type

Observational

Enrollment (Actual)

72

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
      • Bruxelles, Belgium, 1020
        • GSK Investigational Site
      • Bruxelles, Belgium, 1070
        • GSK Investigational Site
      • Deurne, Belgium, 2100
        • GSK Investigational Site
      • Eeklo, Belgium, 9900
        • GSK Investigational Site
      • Genk, Belgium, 3600
        • GSK Investigational Site
      • Gent, Belgium, 9000
        • GSK Investigational Site
      • Kortrijk, Belgium, 8500
        • GSK Investigational Site
      • Namur, Belgium, 5000
        • GSK Investigational Site
      • Roeselaere, Belgium, 8800
        • GSK Investigational Site
      • Sint-Truiden, Belgium, 3800
        • GSK Investigational Site
      • Wilrijk, Belgium, 2610
        • 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

3 months to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children confirmed with G1 and/or P[8] cases from the RotaBel study, children between 14 weeks and <5 years of age, hospitalized for severe gastroenteritis in the study hospitals and who are tested positive for rotavirus

Description

Inclusion Criteria:

Phase I:

• Vaccinated and unvaccinated confirmed G1 and/or P[8] rotavirus gastroenteritis cases from the RotaBel study.

Phase II:

  • A male or a female, born after 1 October 2006 and aged between 14 weeks and < 5 years at the time of hospital admission.
  • Child admitted at the study hospital for severe gastroenteritis during the study period.
  • Onset of severe gastroenteritis ≤14 days prior to admission.
  • Child whose stool sample was tested positive for rotavirus by a hospital routine test.
  • Written informed consent obtained from the parent or guardian of the child.

Exclusion Criteria:

• Child in care.

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 confirmed with G1 and/or P[8] cases from the RotaBel study
Procedure: Stool samples
Stool samples collected and checked for the presence of rotavirus
Cohort B
Children hospitalized for severe gastroenteritis in the study hospitals and tested positive for rotavirus
Procedure: Stool samples
Stool samples collected and checked for the presence of rotavirus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™.
Time Frame: Over a three-year period
Over a three-year period
Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis
Time Frame: Over a three-year period
Over a three-year period
Occurrence of vaccine-derived G1 and/or P[8] encoding gene segments among children hospitalized with rotavirus gastroenteritis due to G1 and/or P[8] strains
Time Frame: Over a three-year period
Over a three-year period
Occurrence of mutated vaccine strains and re-assortments among hospitalized children with vaccine-derived G1 and/or P[8] encoding gene segments
Time Frame: Over a three-year period
Over a three-year period
Clinical characteristics of hospitalized children with vaccine-derived G1 and/or P[8] encoding gene segments, and with vaccine-derived re-assortant strains and vaccine-derived mutated strains
Time Frame: Over a three-year period
Clinical characteristics include symptoms of current gastroenteritis (GE) episode, severity of GE episode by Vesikari score, date of onset of GE episode, diagnosis at admission, diagnosis at discharge, treatment, medical history and co-infections.
Over a three-year period
Occurrence of co-infections due to other common viral intestinal pathogens (norovirus, astrovirus, adenovirus) among hospitalized children with rotavirus gastroenteritis
Time Frame: Over a three-year period
Over a three-year period
Epidemiological characteristics of hospitalized children with vaccine-derived G1 and/or P(8) encoding gene segments, and with vaccine-derived re-assortant strains and vaccine-derived mutated strains
Time Frame: Over a three-year period
Epidemiological characteristics include age, gender, centre of hospitalization, date of admission, date of discharge, duration of hospitalization, etc.
Over a three-year period

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

March 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (ESTIMATE)

April 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112560

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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