Clinical trial NCT01339221: Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Observational
Rotarix™
post-marketing
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-20
Enrollment: 72
Sex: ALL
Minimum age (years): 14
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
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

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.

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 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.

Primary outcomes:
measure: Occurrence of rotavirus gastroenteritis among children hospitalized with acute gastroenteritis who have had opportunity to receive Rotarix™.
timeFrame: Over a three-year period
measure: Occurrence of G1 and/or P[8] rotavirus gastroenteritis among children hospitalized with rotavirus gastroenteritis
timeFrame: Over a three-year period
measure: 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
timeFrame: Over a three-year period
measure: Occurrence of mutated vaccine strains and re-assortments among hospitalized children with vaccine-derived G1 and/or P[8] encoding gene segments
timeFrame: Over a three-year period
measure: 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
timeFrame: Over a three-year period
measure: Occurrence of co-infections due to other common viral intestinal pathogens (norovirus, astrovirus, adenovirus) among hospitalized children with rotavirus gastroenteritis
timeFrame: Over a three-year period
measure: 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
timeFrame: Over a three-year period
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Deurne
country: Belgium
facility: GSK Investigational Site
city: Eeklo
country: Belgium
facility: GSK Investigational Site
city: Genk
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Kortrijk
country: Belgium
facility: GSK Investigational Site
city: Namur
country: Belgium
facility: GSK Investigational Site
city: Roeselaere
country: Belgium
facility: GSK Investigational Site
city: Sint-Truiden
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: