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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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WITHDRAWN

Detailed Description

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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.

Conditions

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Infections, Rotavirus

Study Design

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Observational Model Type

CASE_ONLY

Study Groups

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Cohort A

Children confirmed with G1 and/or P\[8\] cases from the RotaBel study

Stool samples

Intervention Type PROCEDURE

Stool samples collected and checked for the presence of rotavirus

Cohort B

Children hospitalized for severe gastroenteritis in the study hospitals and tested positive for rotavirus

Stool samples

Intervention Type PROCEDURE

Stool samples collected and checked for the presence of rotavirus

Interventions

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Stool samples

Stool samples collected and checked for the presence of rotavirus

Intervention Type PROCEDURE

Eligibility Criteria

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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.