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Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01563146
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : March 12, 2018
Information provided by (Responsible Party):

Brief Summary:
This study aims to collect data and assess the number of rotavirus related hospitalizations in 11 hospitals in Belgium - season 2006-2007 in order to develop proper age-cohort analysis over time.

Condition or disease Intervention/treatment
Infections, Rotavirus Other: Data collection

Detailed Description:
This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2006 until the 31st of May 2007. 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.

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Assessing the Number of Rotavirus Related Hospitalizations in 11 Hospitals in Belgium - Season 2006-2007
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Group/Cohort Intervention/treatment
Group A
All children ≤ 5 years old with a rotavirus detection test (inpatient and ambulatory tests) performed during the period of June the 1st 2006 and May the 31st 2007.
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 2006- May 31st 2007) and analysed for rotavirus, in children aged ≤5 years.

Primary Outcome Measures :
  1. Determination of the absolute number of rotavirus related hospitalisations in children up to five years old. [ Time Frame: From June 1st 2006 up to 1 year ]

Secondary Outcome Measures :
  1. Classification of patients with rotavirus hospitalisation by birth cohorts, gender, time of the event, vaccine coverage status. [ Time Frame: From June 1st 2006 up to 1 year ]
  2. Determination of the duration of rota-related hospitalisation for community acquired and nosocomial infection per birth cohort. [ Time Frame: From June 1st 2006 up to 1 year ]
  3. Evaluation of the herd effect. [ Time Frame: From June 1st 2006 up to 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged ≤5 years undergoing a RV detection test across 11 participating hospitals.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01563146

Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline Identifier: NCT01563146    
Other Study ID Numbers: 116311
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
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Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases