Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 2:54 PM
Study NCT ID:
NCT01177657
Status:
COMPLETED
Last Update Posted:
2012-11-19
First Post:
2010-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Stool sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1944}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-15', 'studyFirstSubmitDate': '2010-08-05', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2012-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of Enzyme Linked Immunosorbent Assay (ELISA) confirmed rotavirus severe gastroenteritis in children fully vaccinated with Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children', 'timeFrame': 'Average time frame: 12-24 months'}], 'secondaryOutcomes': [{'measure': 'Risk of ELISA confirmed rotavirus severe gastroenteritis in children vaccinated with at least one dose of Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children', 'timeFrame': 'Average time frame: 12-24 months'}, {'measure': 'Occurrence of severe gastroenteritis among children admitted to study clinics/hospitals for severe gastroenteritis', 'timeFrame': 'Average time frame: 12-24 months'}, {'measure': 'Occurrence of rotavirus serotypes among children', 'timeFrame': 'Average time frame: 36 months'}]}, 'conditionsModule': {'conditions': ['Rotavirus Gastroenteritis']}, 'referencesModule': {'references': [{'pmid': '21150692', 'type': 'BACKGROUND', 'citation': 'Justino MC, Linhares AC, Lanzieri TM, Miranda Y, Mascarenhas JD, Abreu E, Guerra SF, Oliveira AS, da Silva VB, Sanchez N, Meyer N, Shafi F, Ortega-Barria E, Soriano-Gabarro M, Colindres RE. Effectiveness of the monovalent G1P[8] human rotavirus vaccine against hospitalization for severe G2P[4] rotavirus gastroenteritis in Belem, Brazil. Pediatr Infect Dis J. 2011 May;30(5):396-401. doi: 10.1097/INF.0b013e3182055cc2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.', 'detailedDescription': 'The study will be comprised of two parts: Case-control study and Rotavirus strain surveillance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Gastroenteritis Cohort: Cases will include children born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis the study clinics/hospitals, during the designated study period, Hospital control cohort: Children hospitalized for non gastroenteritis causes, Neighbourhood control cohort: Children without any symptoms of gastroenteritis or severe gastroenteritis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor cases:\n\n* A male or female child born after 6 March 2006 and at least 12 weeks of age.\n* Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period.\n* Onset of severe gastroenteritis ≤ 14 days prior to admission.\n* Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization.\n* Written informed consent obtained from the parent or guardian of the subject.\n\nFor controls:\n\n* Admitted for non-gastroenteritis causes at the same clinic/hospital as the case.\n* Living in the same neighbourhood as the case for at least three consecutive months without any symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/ her parents/ guardians.\n* Being born within +- 2 weeks from the date of birth of the case. If the number required is not available, then the range would be extended to +- 4 weeks, and ultimately up to +- 6 weeks for hospital controls. For neighbourhood controls, the range may be extended to +- 8 weeks.\n* Written informed consent obtained from the parent or guardian of the child.\n\nExclusion Criteria:\n\nFor cases:\n\n* Subject has previously participated as case or control in this study.\n* Onset of severe gastroenteritis \\> 48 hours after admission to the hospital (nosocomial infections).\n\nFor controls:\n\n* For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of his/her parent or guardian or for neighbourhood controls: Child who has symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/her parent or guardian.\n* Exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus influenzae type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B.\n* Child has participated in the past as a case or control in this study.\n* Child living in the same house as the case'}, 'identificationModule': {'nctId': 'NCT01177657', 'briefTitle': 'Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Case-control Study to Evaluate the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalized Children Born After 6 March 2006 and at Least 12 Weeks of Age, in Belem, Brazil', 'orgStudyIdInfo': {'id': '111562'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastroenteritis cohort', 'description': 'Children born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis', 'interventionNames': ['Procedure: Stool sampling']}, {'label': 'Hospital control cohort', 'description': 'Children hospitalized for non gastroenteritis causes'}, {'label': 'Neighbourhood control cohort', 'description': 'Children without any symptoms of gastroenteritis or severe gastroenteritis'}], 'interventions': [{'name': 'Stool sampling', 'type': 'PROCEDURE', 'description': 'Stool samples collected and checked for the presence of rotavirus', 'armGroupLabels': ['Gastroenteritis cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66 090 000', 'city': 'Belém', 'state': 'Pará', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -1.45583, 'lon': -48.50444}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}