Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01435967
First received: September 9, 2011
Last updated: March 6, 2014
Last verified: March 2014

September 9, 2011
March 6, 2014
October 2011
October 2014   (final data collection date for primary outcome measure)
Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™ [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01435967 on ClinicalTrials.gov Archive Site
  • Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region). [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
  • Occurrence of rotavirus detected by laboratory tests at a specific time (month and year). [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
  • Occurrence of rotavirus detected by various types of rotavirus laboratory tests. [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
  • Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population. [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
Observational, Ecological, Database Study on Epidemiology of Hospitalisations With Rotavirus Gastroenteritis Confirmed in Children Aged ≤5 Years, and Any Impact in the Change From Lyophilised to Liquid Formulation of Rotarix™, in Belgium

The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis. This is planned to be assessed by comparing trends of hospitalisations due to laboratory confirmed rotavirus gastroenteritis in children <=5 years of age, before and after introduction of the liquid formulation of the vaccine in Belgium.

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

Children hospitalised due to laboratory confirmed rotavirus gastroenteritis in approximately 8 hospitals across Belgium.

Infections, Rotavirus
Other: Data collection
Data collected when only the lyophilised formulation of Rotarix was in use (which is considered as baseline) will be specifically compared to data collected post the introduction of the liquid formulation. The results will also be compared to available vaccine coverage data for those rotavirus vaccines being used in Belgium.
Cohort A
Children aged <=5 years in Belgium, with opportunity to receive Rotarix, requiring hospitalisation during which rotavirus detection test was performed and with available results.
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
7000
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • Child aged ≤5 years with opportunity to receive lyophilised or liquid formulation of Rotarix™;
  • Hospitalised at one of the participating centres in Belgium;
  • A stool sample has been provided for a rotavirus detection test during the study period;
  • Laboratory test result of rotavirus is available.

Exclusion Criteria:

• None.

Both
up to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01435967
114061
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2014

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