Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-30 @ 11:38 PM
Study NCT ID:
NCT01435967
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2011-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-06', 'studyFirstSubmitDate': '2011-09-09', 'studyFirstSubmitQcDate': '2011-09-15', 'lastUpdatePostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™', 'timeFrame': 'up to 2 years post-introduction of liquid formulation of Rotarix™.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region).', 'timeFrame': 'up to 2 years post-introduction of liquid formulation of Rotarix™.'}, {'measure': 'Occurrence of rotavirus detected by laboratory tests at a specific time (month and year).', 'timeFrame': 'up to 2 years post-introduction of liquid formulation of Rotarix™.'}, {'measure': 'Occurrence of rotavirus detected by various types of rotavirus laboratory tests.', 'timeFrame': 'up to 2 years post-introduction of liquid formulation of Rotarix™.'}, {'measure': 'Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population.', 'timeFrame': 'up to 2 years post-introduction of liquid formulation of Rotarix™.'}]}, 'conditionsModule': {'keywords': ['Rotarix™', 'Observational', 'ecological'], 'conditions': ['Infections, Rotavirus']}, 'referencesModule': {'references': [{'pmid': '27373141', 'type': 'DERIVED', 'citation': 'Raes M, Strens D, Kleintjens J, Biundo E, Morel T, Vyse A. Epidemiological trends for hospital admissions for acute rotavirus gastroenteritis in Belgium following the introduction of routine rotavirus vaccination and the subsequent switch from lyophilized to liquid formulation of Rotarix. Epidemiol Infect. 2016 Oct;144(14):3017-3024. doi: 10.1017/S0950268816001151. Epub 2016 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis. This is planned to be assessed by comparing trends of hospitalisations due to laboratory confirmed rotavirus gastroenteritis in children \\<=5 years of age, before and after introduction of the liquid formulation of the vaccine in Belgium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children hospitalised due to laboratory confirmed rotavirus gastroenteritis in approximately 8 hospitals across Belgium.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects must satisfy ALL the following criteria at study entry:\n\n* Child aged ≤5 years with opportunity to receive lyophilised or liquid formulation of Rotarix™;\n* Hospitalised at one of the participating centres in Belgium;\n* A stool sample has been provided for a rotavirus detection test during the study period;\n* Laboratory test result of rotavirus is available.\n\nExclusion Criteria:\n\n• None.'}, 'identificationModule': {'nctId': 'NCT01435967', 'briefTitle': 'Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '114061'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Children aged \\<=5 years in Belgium, with opportunity to receive Rotarix, requiring hospitalisation during which rotavirus detection test was performed and with available results.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Data collected when only the lyophilised formulation of Rotarix was in use (which is considered as baseline) will be specifically compared to data collected post the introduction of the liquid formulation. The results will also be compared to available vaccine coverage data for those rotavirus vaccines being used in Belgium.', 'armGroupLabels': ['Cohort A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '8900', 'city': 'Ieper', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.85114, 'lon': 2.88569}}, {'zip': '1090', 'city': 'Jette', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '5330', 'city': 'Yvoir', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}