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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563159
First received: March 1, 2012
Last updated: November 19, 2015
Last verified: November 2015

March 1, 2012
November 19, 2015
March 2015
February 2016   (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 Rotavirus Positive Test Results in 11 Hospitals in Belgium From 2005 to 2013: the RotaBIS Study (Rotavirus Belgian Impact Study)
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.
Infections, Rotavirus
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.
 
Active, not recruiting
1
February 2016
February 2016   (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:

Both
up to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01563159
116312
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2015

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