Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007
This study aims to collect data and assess the number of rotavirus related hospitalizations in 11 hospitals in Belgium - season 2006-2007 in order to develop proper age-cohort analysis over time.
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Retrospective
|Official Title:||Assessing the Number of Rotavirus Related Hospitalizations in 11 Hospitals in Belgium - Season 2006-2007|
- Determination of the absolute number of rotavirus related hospitalisations in children up to five years old. [ Time Frame: From June 1st 2006 up to 1 year ] [ Designated as safety issue: No ]
- Classification of patients with rotavirus hospitalisation by birth cohorts, gender, time of the event, vaccine coverage status. [ Time Frame: From June 1st 2006 up to 1 year ] [ Designated as safety issue: No ]
- Determination of the duration of rota-related hospitalisation for community acquired and nosocomial infection per birth cohort. [ Time Frame: From June 1st 2006 up to 1 year ] [ Designated as safety issue: No ]
- Evaluation of the herd effect. [ Time Frame: From June 1st 2006 up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||December 2014|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
All children ≤ 5 years old with a rotavirus detection test (inpatient and ambulatory tests) performed during the period of June the 1st 2006 and May the 31st 2007.
Other: Data collection
Each participating centre will be requested to generate a coded list of all stool samples taken during the study period (June 1st 2006- May 31st 2007) and analysed for rotavirus, in children aged ≤5 years.
This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2006 until the 31st of May 2007. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563146
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|