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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01563146
Other study ID # 116311
Secondary ID
Status Completed
Phase N/A
First received March 1, 2012
Last updated March 9, 2018
Start date February 1, 2016
Est. completion date December 31, 2017

Study information

Verified date March 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to collect data and assess the number of rotavirus related hospitalizations in 11 hospitals in Belgium - season 2006-2007 in order to develop proper age-cohort analysis over time.


Description:

This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2006 until the 31st of May 2007. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Years
Eligibility Inclusion Criteria:

- Child aged =5 years;

- A stool sample has been provided for a rotavirus detection test during the study period;

- Laboratory test result of rotavirus is available.

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection
Each participating centre will be requested to generate a coded list of all stool samples taken during the study period (June 1st 2006- May 31st 2007) and analysed for rotavirus, in children aged =5 years.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of the absolute number of rotavirus related hospitalisations in children up to five years old. From June 1st 2006 up to 1 year
Secondary Classification of patients with rotavirus hospitalisation by birth cohorts, gender, time of the event, vaccine coverage status. From June 1st 2006 up to 1 year
Secondary Determination of the duration of rota-related hospitalisation for community acquired and nosocomial infection per birth cohort. From June 1st 2006 up to 1 year
Secondary Evaluation of the herd effect. From June 1st 2006 up to 1 year
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