NCT01563159

Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011

Assessing the Rotavirus Positive Test Results in 11 Hospitals in Belgium From 2005 to 2013: the RotaBIS Study (Rotavirus Belgian Impact Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

This study aims to confirm the statistically significant decline in rotavirus related and in acute gastro-enteritis (AGE) related hospital admissions that was observed in 11 participating hospitals, after the introduction of RV vaccines in Belgium in 2006.

Detailed description

This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2010 until the 31st of May 2011. 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.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
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 2010- May 31st 2011) and analysed for rotavirus, in children aged ≤5 years.

Timeline

• Start date: 2015-03-31
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2012-03-26
• Last updated: 2018-03-14