Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-30 @ 11:38 PM
Study NCT ID:
NCT01435967
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2011-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: