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: January 21, 2013

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2011

Last Updated Date

January 21, 2013

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01435967 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Ecologic or Community
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Rotavirus Gastroenteritis

Intervention ^ICMJE

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.

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

7000

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01435967

Other Study ID Numbers ^ICMJE

114061

Has Data Monitoring Committee

Not Provided

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

July 2012

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

To Top