Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007

Infections, Rotavirus Clinical Trial

Official title:

Assessing the Number of Rotavirus Related Hospitalizations in 11 Hospitals in Belgium - Season 2006-2007

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563146
• Other study ID #: 116311
• 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
• 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:

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

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