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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01339221
First received: April 14, 2011
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Rotavirus Gastroenteritis
Procedure: Stool samples

Study Type: Observational
Study Design: Observational Model: Case-Only
Official 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™. [ Time Frame: Over a three-year period ] [ Designated as safety issue: No ]
  • Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis [ Time Frame: Over a three-year period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Epidemiological characteristics include age, gender, centre of hospitalization, date of admission, date of discharge, duration of hospitalization, etc.


Biospecimen Retention:   Samples Without DNA

Stool samples


Enrollment: 26
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort A
Children confirmed with G1 and/or P[8] cases from the RotaBel study
Procedure: Stool samples
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
Procedure: Stool samples
Stool samples collected and checked for the presence of rotavirus

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.

  Eligibility

Ages Eligible for Study:   14 Weeks to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children confirmed with G1 and/or P[8] cases from the RotaBel study, children between 14 weeks and <5 years of age, hospitalized for severe gastroenteritis in the study hospitals and who are tested positive for rotavirus

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339221

Locations
Belgium
GSK Investigational Site
Brussels, Belgium, 1020
GSK Investigational Site
Deurne, Belgium, 2100
GSK Investigational Site
Eeklo, Belgium, 9900
GSK Investigational Site
Genk, Belgium, 3600
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Kortrijk, Belgium, 8500
GSK Investigational Site
Namur, Belgium, 5000
GSK Investigational Site
Roeselaere, Belgium, 8800
GSK Investigational Site
Sint-Truiden, Belgium, 3800
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01339221     History of Changes
Other Study ID Numbers: 112560
Study First Received: April 14, 2011
Last Updated: October 11, 2012
Health Authority: Belgium: Agence Fédérale des Médicaments et des Produits de la Santé

Keywords provided by GlaxoSmithKline:
Observational
Rotarix™
post-marketing

Additional relevant MeSH terms:
Gastroenteritis
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 24, 2014