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

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.

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Key information

Conditions

Infections, Rotavirus Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

Absolute number of rotavirus related hospitalisations in children up to five years old.

Time frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)

Secondary outcomes

Proportion of rotavirus positive tests on the total number of rota detection tests

Time frame: During 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.

Time frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Mar 26, 2012
Registry last updated: Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed