This trial is active, not recruiting.

Condition infections, rotavirus
Treatment data collection
Sponsor GlaxoSmithKline
Start date March 2015
End date February 2016
Trial size 1 participant
Trial identifier NCT01563159, 116312


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective retrospective
All 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.
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.

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

Classification of patients with rotavirus hospitalisation by age-group of 1-year, gender, time of the event, vaccine coverage status.
time frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
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)

Eligibility Criteria

Male or female participants up to 5 years old.

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:

Additional Information

Official title Assessing the Rotavirus Positive Test Results in 11 Hospitals in Belgium From 2005 to 2013: the RotaBIS Study (Rotavirus Belgian Impact Study)
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.