Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-28 @ 1:23 AM
Study NCT ID:
NCT04054492
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 604}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-11', 'studyFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2019-08-11', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the occurrence of adverse events', 'timeFrame': '6 months', 'description': 'analyse the numbers and rates of participants who experience adverse events following immunization'}], 'primaryOutcomes': [{'measure': 'Seroconversion rates at both baseline and 30 days after the 3rd vaccination', 'timeFrame': '4 months', 'description': 'Determine the seroconversion rates of poliovirus (types I,II,III）at both baseline and 30 days after the 3rd vaccination'}], 'secondaryOutcomes': [{'measure': 'Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination', 'timeFrame': '4 months', 'description': 'Measure neutralizing antibody titers against poliovirus type I, II and III at both baseline and 30 days after the 3rd vaccination'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaccination', 'Reaction - Vaccine']}, 'referencesModule': {'references': [{'pmid': '32747216', 'type': 'DERIVED', 'citation': 'Yan S, Chen H, Zhang Z, Chang S, Xiao Y, Luo L, Zhang Z, Sun L, Chen X, Yang Y, Shi X, Guo Y, Sun Y, Li H, Li N, Han S, Ma M, Yang X. Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China. Vaccine. 2020 Sep 11;38(40):6274-6279. doi: 10.1016/j.vaccine.2020.07.042. Epub 2020 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.', 'detailedDescription': 'A phase 4 clinical trial is designed to evaluate the safety and immunogenicity of different sequential immunization schedules of Sabin IPV and bOPV. To be specific, the subjects were divided into 3 groups.\n\nGroup 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.\n\nGroup 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.\n\nGroup 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.\n\nBlood samples were collected before vaccination and 30 days after the third dose. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of the 3 immunization schedule groups were also monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '89 Days', 'minimumAge': '60 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects aged from 60 days to 89 days old at the date of recruitment;\n* with informed consent signed by parent(s) or guardians;\n* parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;\n* subjects did not receive any vaccination within 14 days;\n* axillary temperature ≤37.0℃\n\nExclusion Criteria:\n\n* allergic to any ingredient of vaccine or with allergy history to any vaccine;\n* acute febrile disease or infectious disease;\n* serious chronic diseases;\n* any other factor that makes the investigator determines the subject is unsuitable for this study;'}, 'identificationModule': {'nctId': 'NCT04054492', 'briefTitle': 'To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV', 'organization': {'class': 'INDUSTRY', 'fullName': 'China National Biotec Group Company Limited'}, 'officialTitle': 'A Randomized, Multi-center, Controlled Clinical Trial for Evaluating the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV', 'orgStudyIdInfo': {'id': 'sIPV-2018XG-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sIPV+bOPV+bOPV', 'description': '202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively', 'interventionNames': ['Biological: Sabin-IPV+bOPV+bOPV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sIPV+sIPV+bOPV', 'description': '197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively', 'interventionNames': ['Biological: Sabin-IPV+Sabin-IPV+bOPV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sIPV+sIPV+sIPV', 'description': '205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively', 'interventionNames': ['Biological: Sabin-IPV+Sabin-IPV+Sabin-IPV']}], 'interventions': [{'name': 'Sabin-IPV+bOPV+bOPV', 'type': 'BIOLOGICAL', 'description': '202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively', 'armGroupLabels': ['sIPV+bOPV+bOPV']}, {'name': 'Sabin-IPV+Sabin-IPV+bOPV', 'type': 'BIOLOGICAL', 'description': '197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively', 'armGroupLabels': ['sIPV+sIPV+bOPV']}, {'name': 'Sabin-IPV+Sabin-IPV+Sabin-IPV', 'type': 'BIOLOGICAL', 'description': '205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively', 'armGroupLabels': ['sIPV+sIPV+sIPV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010031', 'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Inner Mongolia Autonomous Region Center for Diseases Prevention and Control', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}], 'overallOfficials': [{'name': 'Shaohong Yan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inner Mongolia Autonomous Region Center for Diseases Prevention and Control'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Biotec Group Company Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Inner Mongolia Autonomous Region Center for Diseases Prevention and Control', 'class': 'UNKNOWN'}, {'name': 'Shaanxi Provincial Center for Disease Control and Prevention', 'class': 'OTHER'}, {'name': 'Hubei Provincial Center for Disease Control and Prevention', 'class': 'OTHER'}, {'name': 'Peking University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}