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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
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

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Procedure: Stool samples


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 14 Weeks
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Children confirmed with G1 and/or P[8] cases from the RotaBel study | Procedure: Stool samples<br>* Stool samples collected and checked for the presence of rotavirus<br>|
| Cohort B<br>Children hospitalized for severe gastroenteritis in the study hospitals and tested positive for rotavirus | Procedure: Stool samples<br>* Stool samples collected and checked for the presence of rotavirus<br>|

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™. |  | Over a three-year period | 
| Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis |  | 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 |  | 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 |  | 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 | 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 |  | 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 | Epidemiological characteristics include age, gender, centre of hospitalization, date of admission, date of discharge, duration of hospitalization, etc. | Over a three-year period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotarix™, Observational, post-marketing