Skip to main content
OpenTrials
Completed

NCT Number: NCT01339221

Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infections, Rotavirus Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

14 week–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Brussels, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stool samples

Procedure

Stool samples collected and checked for the presence of rotavirus

Primary outcomes

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

    Time frame: Over a three-year period

  2. Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis

    Time frame: Over a three-year period

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2011
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.