Infections, Rotavirus Clinical Trial
Official title:
Assessing the Rotavirus Positive Test Results in 11 Hospitals in Belgium From 2005 to 2013: the RotaBIS Study (Rotavirus Belgian Impact Study)
Verified date | March 2018 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to confirm the statistically significant decline in rotavirus related and in acute gastro-enteritis (AGE) related hospital admissions that was observed in 11 participating hospitals, after the introduction of RV vaccines in Belgium in 2006.
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: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute number of rotavirus related hospitalisations in children up to five years old. | During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year) | ||
Secondary | Proportion of rotavirus positive tests on the total number of rota detection tests | Total number of rota detection tests and number of rotavirus positive tests of the study year will be determined by age-group of 1-year, gender, time of the event, vaccine coverage status. | During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year) | |
Secondary | The duration of rota-related hospitalisation for community acquired and nosocomial infection. | During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year) |
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