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OpenTrials
Completed

NCT Number: NCT01435967

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

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.

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Key information

Conditions

Infections, Rotavirus Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

  1. 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™.

Secondary outcomes

  1. 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™.

  2. 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™.

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

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

  4. 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™.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2011
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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