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

GlaxoSmithKline72 enrolled

Overview

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.

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

Conditions

Infections, Rotavirus

Interventions

Stool samplesPROCEDURE

Stool samples collected and checked for the presence of rotavirus

Eligibility

Sex: ALLMin age: 14 WeeksMax age: 5 Years

Medical Language ↔ Plain English

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.

Locations (11)

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Deurne, Belgium

GSK Investigational Site

Eeklo, Belgium

GSK Investigational Site

Genk, Belgium

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Kortrijk, Belgium

GSK Investigational Site

Namur, Belgium

GSK Investigational Site

Roeselaere, Belgium

GSK Investigational Site

Sint-Truiden, Belgium

...and 1 more locations

Outcomes

Primary Outcomes

Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™.