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

NCT01435967 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2015-03-09

No results posted yet for this study

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.

Conditions

  • Infections, Rotavirus

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01435967 on ClinicalTrials.gov