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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01339221
Other study ID # 112560
Secondary ID
Status Completed
Phase N/A
First received April 14, 2011
Last updated January 16, 2017
Start date March 2011
Est. completion date June 2012

Study information

Verified date January 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 14 Weeks to 5 Years
Eligibility 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


Intervention

Procedure:
Stool samples
Stool samples collected and checked for the presence of rotavirus

Locations

Country Name City State
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Deurne
Belgium GSK Investigational Site Eeklo
Belgium GSK Investigational Site Genk
Belgium GSK Investigational Site Gent
Belgium GSK Investigational Site Kortrijk
Belgium GSK Investigational Site Namur
Belgium GSK Investigational Site Roeselaere
Belgium GSK Investigational Site Sint-Truiden
Belgium GSK Investigational Site Wilrijk

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™. Over a three-year period
Primary Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis Over a three-year period
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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