A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia
NCT ID: NCT01733849
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1266 participants
OBSERVATIONAL
2012-12-31
2014-06-30
Brief Summary
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Detailed Description
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Stool samples will be collected from all enrolled subjects at Visit 1 (Day 0) and tested immediately after collection. The stool sample will be stored for 24 hours only, in case the test cannot be performed immediately after collection.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group Bulgaria
Subjects in this group include infants/children from Bulgaria, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
Stool sample
Samples will be tested to determine the presence or absence of rotavirus.
Data collection
Log books
Group Latvia
Subjects in this group include infants/children from Latvia, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
Stool sample
Samples will be tested to determine the presence or absence of rotavirus.
Data collection
Log books
Interventions
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Stool sample
Samples will be tested to determine the presence or absence of rotavirus.
Data collection
Log books
Eligibility Criteria
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Inclusion Criteria
* A male or female infant/child less than five years of age at the time of the GP/paediatrician visit. A child becomes ineligible on the day of her/his fifth birthday.
* Written informed consent obtained from the parents/legally acceptable representative (LARs) of the subject.
* Subjects who the investigator believes that his/her, parents/LARs can and will comply with the requirements of the protocol.
Exclusion Criteria
5 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Burgas, , Bulgaria
GSK Investigational Site
Burgas, , Bulgaria
GSK Investigational Site
Dobrich, , Bulgaria
GSK Investigational Site
Pazardzhik, , Bulgaria
GSK Investigational Site
Pleven, , Bulgaria
GSK Investigational Site
Plovdiv, , Bulgaria
GSK Investigational Site
Rousse, , Bulgaria
GSK Investigational Site
Sliven, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Stara Zagora, , Bulgaria
GSK Investigational Site
Varna, , Bulgaria
GSK Investigational Site
Veliko Tarnovo, , Bulgaria
GSK Investigational Site
Balvi, , Latvia
GSK Investigational Site
Bauska, , Latvia
GSK Investigational Site
Brocēni, , Latvia
GSK Investigational Site
Carnikava, , Latvia
GSK Investigational Site
Daugavpils, , Latvia
GSK Investigational Site
Daugavpils, , Latvia
GSK Investigational Site
Druva, , Latvia
GSK Investigational Site
Erglu Pagasts, , Latvia
GSK Investigational Site
Grobiņa, , Latvia
GSK Investigational Site
Ikšķile, , Latvia
GSK Investigational Site
Jelgava, , Latvia
GSK Investigational Site
Jelgava, , Latvia
GSK Investigational Site
Jelgava, , Latvia
GSK Investigational Site
Jelgava, , Latvia
GSK Investigational Site
Jēkabpils, , Latvia
GSK Investigational Site
Kuldīga, , Latvia
GSK Investigational Site
Liepāja, , Latvia
GSK Investigational Site
Limbaži, , Latvia
GSK Investigational Site
Līvāni, , Latvia
GSK Investigational Site
Madona, , Latvia
GSK Investigational Site
Ogre, , Latvia
GSK Investigational Site
Ozolnieki, , Latvia
GSK Investigational Site
Piņķi, , Latvia
GSK Investigational Site
Rēzekne, , Latvia
GSK Investigational Site
Rēzekne, , Latvia
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
Ropaži, , Latvia
GSK Investigational Site
Sigulda, , Latvia
GSK Investigational Site
Tukums, , Latvia
GSK Investigational Site
Valmiera, , Latvia
GSK Investigational Site
Valmiera, , Latvia
GSK Investigational Site
Vangaži, , Latvia
GSK Investigational Site
Ventspils, , Latvia
GSK Investigational Site
Ventspils, , Latvia
Countries
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References
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Tafalla M, Gardovska D, Gopala K, Kozlovska L. Primary care-based surveillance to estimate the proportion of rotavirus gastroenteritis among Latvian children below 5 years of age with acute gastroenteritis. Hum Vaccin Immunother. 2019;15(6):1272-1278. doi: 10.1080/21645515.2018.1534515. Epub 2018 Oct 31.
Tiholova M, Gopala K, Berberova M, Strokova-Stoilova M, Tafalla M. Rotavirus gastroenteritis in children less than five years of age in primary care settings in Bulgaria: an observational study. Germs. 2016 Sep 1;6(3):97-105. doi: 10.11599/germs.2016.1095. eCollection 2016 Sep.
Other Identifiers
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116621
Identifier Type: -
Identifier Source: org_study_id
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