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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2015 |
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Main ID: |
NCT01435967 |
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Date of registration:
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09/09/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
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Scientific title:
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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 |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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1 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01435967 |
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Study type:
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Observational |
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Study design:
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Observational Model: Ecologic or Community, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
5 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infections, Rotavirus
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Intervention(s)
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Other: Data collection
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Primary Outcome(s)
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Occurrence of rotavirus in hospitalised children aged =5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™
[Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™.]
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Secondary Outcome(s)
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Occurrence of rotavirus detected by various types of rotavirus laboratory tests.
[Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™.]
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Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children =5 years of age in the Belgian population.
[Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™.]
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Occurrence of rotavirus detected by laboratory tests at a specific time (month and year).
[Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™.]
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Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region).
[Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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