NCT01435967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

September 9, 2011

Last Update Submit

March 6, 2015

Conditions

Infections, Rotavirus

Keywords

Rotarix™Observationalecological

Outcome Measures

Primary Outcomes (1)

  • Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™

    up to 2 years post-introduction of liquid formulation of Rotarix™.

Secondary Outcomes (4)

  • Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region).

    up to 2 years post-introduction of liquid formulation of Rotarix™.

  • Occurrence of rotavirus detected by laboratory tests at a specific time (month and year).

    up to 2 years post-introduction of liquid formulation of Rotarix™.

  • Occurrence of rotavirus detected by various types of rotavirus laboratory tests.

    up to 2 years post-introduction of liquid formulation of Rotarix™.

  • Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population.

    up to 2 years post-introduction of liquid formulation of Rotarix™.

Study Arms (1)

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.

Other: Data collection

Interventions

Data collectionOTHER

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

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

GSK Investigational Site

Antwerp, 2020, Belgium

Location

GSK Investigational Site

Bonheiden, 2820, Belgium

Location

GSK Investigational Site

Charleroi, 6000, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Hasselt, 3500, Belgium

Location

GSK Investigational Site

Ieper, 8900, Belgium

Location

GSK Investigational Site

Jette, 1090, Belgium

Location

GSK Investigational Site

Yvoir, 5330, Belgium

Location

Related Publications (1)

  • Raes M, Strens D, Kleintjens J, Biundo E, Morel T, Vyse A. Epidemiological trends for hospital admissions for acute rotavirus gastroenteritis in Belgium following the introduction of routine rotavirus vaccination and the subsequent switch from lyophilized to liquid formulation of Rotarix. Epidemiol Infect. 2016 Oct;144(14):3017-3024. doi: 10.1017/S0950268816001151. Epub 2016 Jul 4.

    PMID: 27373141DERIVED

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 19, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

BE(8)