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

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ClinicalTrials.gov Identifier: NCT01563159
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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 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.

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Assessing the Rotavirus Positive Test Results in 11 Hospitals in Belgium From 2005 to 2013: the RotaBIS Study (Rotavirus Belgian Impact Study)
Actual Study Start Date : March 31, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 2010 and May the 31st 2011.
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 2010- May 31st 2011) and analysed for rotavirus, in children aged ≤5 years.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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) ]


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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.
Criteria

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:


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 ClinicalTrials.gov identifier (NCT number): NCT01563159


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563159     History of Changes
Other Study ID Numbers: 116312
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Belgium
hospitals
Rotavirus

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases