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

Completed

• Conditions: Infections, Rotavirus
• Interventions: Procedure: Stool samples

• Registration Number: NCT01339221
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	Stool samples	Children confirmed with G1 and/or P\[8\] cases from the RotaBel study
Cohort B	Stool samples	Children hospitalized for severe gastroenteritis in the study hospitals and tested positive for rotavirus

Primary Outcome Measures

Name	Time	Method
Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™.	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
Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis	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
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
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	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.
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	Over a three-year period	Epidemiological characteristics include age, gender, centre of hospitalization, date of admission, date of discharge, duration of hospitalization, etc.

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Wilrijk, Belgium