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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01563159
Enrollment
1
Registered
2012-03-26
Start date
2015-03-31
Completion date
2017-12-31
Last updated
2018-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Rotavirus

Keywords

Belgium, hospitals, Rotavirus

Brief 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.

Interventions

OTHERData 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.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

Inclusion criteria

* Child aged ≤5 years; * A stool sample has been provided for a rotavirus detection test during the study period; * Laboratory test result of rotavirus is available.

Exclusion criteria

Not applicable.

Design outcomes

Primary

MeasureTime frame
Absolute number of rotavirus related hospitalisations in children up to five years old.During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)

Secondary

MeasureTime frameDescription
Proportion of rotavirus positive tests on the total number of rota detection testsDuring the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)Total number of rota detection tests and number of rotavirus positive tests of the study year will be determined by age-group of 1-year, gender, time of the event, vaccine coverage status.
The duration of rota-related hospitalisation for community acquired and nosocomial infection.During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026