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

This study is not yet open for participant recruitment.
Verified April 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563159
First received: March 1, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes

March 1, 2012
April 5, 2013
June 2013
September 2013   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01563159 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011
Assessing the Number of Rotavirus Related Hospitalizations in 11 Hospitals 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.

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.
Observational
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Children aged ≤5 years undergoing a RV detection test across 11 participating hospitals.
Rotavirus Vaccines
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.
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.
Intervention: Other: Data collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
up to 5 Years
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Not Provided
 
NCT01563159
116312
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP