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

Completed
Conditions
Infections, Rotavirus
Interventions
Other: Data collection
Registration Number
NCT01563159
Lead Sponsor
GlaxoSmithKline
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Group AData collectionAll children ≤ 5 years old with a rotavirus detection test (inpatient and ambulatory tests) performed during the period of June the 1st 2010 and May the 31st 2011.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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)
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