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

NCT01339221 | Completed

• 1 other identifier: 112560
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 11

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.

Conditions

Infections, Rotavirus

Keywords

Observational; Rotarix™; post-marketing

Outcome Measures

Primary Outcomes (7)

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

  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 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

• 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

• 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

• 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

• 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

Study Arms (2)

Cohort A

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

Procedure: Stool samples

Cohort B

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

Procedure: Stool samples

Interventions

Stool samples PROCEDURE

Stool samples collected and checked for the presence of rotavirus

Cohort A; Cohort B

Eligibility Criteria

• Age: 14 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Child in care.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Brussels, 1020, Belgium

Location

GSK Investigational Site

Brussels, 1070, Belgium

Location

GSK Investigational Site

Deurne, 2100, Belgium

Location

GSK Investigational Site

Eeklo, 9900, Belgium

Location

GSK Investigational Site

Genk, 3600, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Kortrijk, 8500, Belgium

Location

GSK Investigational Site

Namur, 5000, Belgium

Location

GSK Investigational Site

Roeselaere, 8800, Belgium

Location

GSK Investigational Site

Sint-Truiden, 3800, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 20, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

BE (11)