Trials / Completed
CompletedNCT01339221
Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 72 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 14 Weeks – 5 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Stool samples | Stool samples collected and checked for the presence of rotavirus |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2011-04-20
- Last updated
- 2017-01-18
Locations
11 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT01339221. Inclusion in this directory is not an endorsement.