Clinical trial NCT01435967: Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Rotarix™
Observational
ecological
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 1
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children hospitalised due to laboratory confirmed rotavirus gastroenteritis in approximately 8 hospitals across 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™
timeFrame: up to 2 years post-introduction of liquid formulation of Rotarix™.
Secondary outcomes:
measure: Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region).
timeFrame: up to 2 years post-introduction of liquid formulation of Rotarix™.
measure: Occurrence of rotavirus detected by laboratory tests at a specific time (month and year).
timeFrame: up to 2 years post-introduction of liquid formulation of Rotarix™.
measure: Occurrence of rotavirus detected by various types of rotavirus laboratory tests.
timeFrame: up to 2 years post-introduction of liquid formulation of Rotarix™.
measure: Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population.
timeFrame: up to 2 years post-introduction of liquid formulation of Rotarix™.
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Bonheiden
country: Belgium
facility: GSK Investigational Site
city: Charleroi
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Hasselt
country: Belgium
facility: GSK Investigational Site
city: Ieper
country: Belgium
facility: GSK Investigational Site
city: Jette
country: Belgium
facility: GSK Investigational Site
city: Yvoir
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.