Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT00981669
Status:
COMPLETED
Last Update Posted:
2013-04-25
First Post:
2009-09-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rotavirus Vaccine Produced by Butantan Institute
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D022243', 'term': 'Rotavirus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alexrp@butantan.gov.br', 'phone': '+5511-2627-9372', 'title': 'Alexander Roberto Precioso', 'phoneExt': '9372', 'organization': 'Instituto Butantan'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The vaccine candidate needs to be evaluated further in larger trials, among the target population.'}}, 'adverseEventsModule': {'timeFrame': 'Complaints and solicited symptoms were investigated following the first five days after vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Rotavirus Vaccine', 'description': '3 doses with 6 weeks interval', 'otherNumAtRisk': 39, 'otherNumAffected': 10, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '3 doses with 6 weeks interval', 'otherNumAtRisk': 40, 'otherNumAffected': 9, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Anti-rotavirus IgA Level.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotavirus Vaccine', 'description': '3 doses with 6 weeks interval'}, {'id': 'OG001', 'title': 'Placebo', 'description': '3 doses with 6 weeks interval'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.71'}, {'value': '0.35', 'groupId': 'OG001', 'lowerLimit': '0.30', 'upperLimit': '0.46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'before each dose (total of doses:3) and after 6 weeks of the third dose', 'description': 'It was evaluated by anti-rotavirus IgA levels in terms of optical density. Pre-vaccination levels of anti-rotavirus antibodies were not considered as an exclusion criterion. Seroconversion was considered as a fourfold increase in IgA titers. The proportion of seroconverters in both groups was compared. IgA levels in optical density were not converted to any unit of measure.', 'unitOfMeasure': 'Arbitrary units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'As in most phase I trials, sample size was not calculated to provide statistically significant differences between groups. Rather, a descriptive analysis on the frequency of AE and immunogenicity data was undertaken.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotavirus Vaccine', 'description': '3 doses with 6 weeks interval'}, {'id': 'OG001', 'title': 'Placebo', 'description': '3 doses with 6 weeks interval'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within the first five days post-vaccination.', 'description': 'Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rotavirus Vaccine', 'description': '3 doses with 6 weeks interval'}, {'id': 'FG001', 'title': 'Placebo', 'description': '3 doses with 6 weeks interval'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period: From February to August 2009.79 healthy adult volunteers from 18 to 40 years of age were selected. Participants were screened for eligibility and enrolled by the investigators following the signing of an informed consent. Due to a recommendation from ANVISA, female volunteers were not allowed to be recruited.', 'preAssignmentDetails': '98 potential volunteers were interviewed, 80 of them were enrolled: 40 volunteers were allocated to receive the investigational product (rotavirus vaccine) and 40 were allocated to receive placebo; 79 completed the follow-up. Before randomization 18 volunteers were excluded, 3 refused to participate and 15 had screening failure'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rotavirus Vaccine', 'description': '3 doses with 6 weeks interval'}, {'id': 'BG001', 'title': 'Placebo', 'description': '3 doses with 6 weeks interval'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '28.2', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '28.7', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'In the vaccine gorup one volunteer was not considered for the final analysis because He received the second dose of the vaccine in an anapropriate interval.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-15', 'studyFirstSubmitDate': '2009-09-17', 'resultsFirstSubmitDate': '2013-02-04', 'studyFirstSubmitQcDate': '2009-09-21', 'lastUpdatePostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-15', 'studyFirstPostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events.', 'timeFrame': 'Within the first five days post-vaccination.', 'description': 'Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.'}], 'secondaryOutcomes': [{'measure': 'Anti-rotavirus IgA Level.', 'timeFrame': 'before each dose (total of doses:3) and after 6 weeks of the third dose', 'description': 'It was evaluated by anti-rotavirus IgA levels in terms of optical density. Pre-vaccination levels of anti-rotavirus antibodies were not considered as an exclusion criterion. Seroconversion was considered as a fourfold increase in IgA titers. The proportion of seroconverters in both groups was compared. IgA levels in optical density were not converted to any unit of measure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['brazilian pentavalent rotavirus vaccine', 'safety', 'tolerability', 'immunogenicity'], 'conditions': ['Rotavirus Infections']}, 'referencesModule': {'references': [{'pmid': '19551286', 'type': 'BACKGROUND', 'citation': 'Higashi HG, Luna E, Precioso AR, Vilela M, Kubrusly FS, Dias WO, Raw I. Acellular and "low" pertussis vaccines: adverse events and the role of mutations. Rev Inst Med Trop Sao Paulo. 2009 May-Jun;51(3):131-4. doi: 10.1590/s0036-46652009000300002.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.', 'detailedDescription': 'The Brazilian National Immunization Program (PNI) has introduced a oral monovalent vaccine against rotavirus for infants in its immunization schedule since 2006. Its introduction increased the Brazilian Ministry of Health budget because the vaccination in Brazil is free of charge. An agreement between Path Foundation and Butantan Institute has made possible the transfer of technology to Butantan Institute to produce, at a reduced cost, a pentavalent rotavirus vaccine including the the rotavirus serotypes more frequent in Brazil.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male healthy\n* Age ≥18-40 years\n* Not taking immunosuppressive drugs\n* No clinical history of gastrointestinal diseases or surgeries\n* No history of cardiac, neurologic, immunologic or endocrine diseases\n* Normal eligibility laboratory tests\n* To be willing to participate and sign the informed consent form\n* No participation in another clinical trial in the past 6 months\n\nExclusion Criteria:\n\n* Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study'}, 'identificationModule': {'nctId': 'NCT00981669', 'briefTitle': 'Rotavirus Vaccine Produced by Butantan Institute', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Butantan Institute'}, 'officialTitle': 'Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation', 'orgStudyIdInfo': {'id': '1242/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rotavirus vaccine', 'description': '3 doses with 6 weeks interval', 'interventionNames': ['Biological: rotavirus vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '3 doses with 6 weeks interval', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'rotavirus vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['brazilian rotavirus vaccine'], 'description': '3 doses with 6 weeks interval', 'armGroupLabels': ['rotavirus vaccine']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'otherNames': ['butantan placebo'], 'description': '3 doses with 6 weeks interval', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Alexander R Precioso, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Butantan Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butantan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}