Infections, Rotavirus
Conditions
Keywords
Observational, Rotarix™, post-marketing
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.
Interventions
PROCEDUREStool samples
Stool samples collected and checked for the presence of rotavirus
Sponsors
GlaxoSmithKline
Study design
Observational model
CASE_ONLY
Eligibility
Sex/Gender
ALL
Age
14 Weeks to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Over a three-year period | 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 | 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 | Over a three-year period | Epidemiological characteristics include age, gender, centre of hospitalization, date of admission, date of discharge, duration of hospitalization, etc. |
Countries
Belgium
Outcome results
None listed