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

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Infections, Rotavirus

Treatments

Procedure: Stool samples

Study type

Observational

Funder types

Industry

Identifiers

NCT01339221

112560

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

14 weeks to 5 years old

Volunteers

No Healthy Volunteers

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.