Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-28 @ 6:10 PM
Study NCT ID:
NCT03546634
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2018-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-05-23', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion rate', 'timeFrame': '10 months', 'description': 'Determine whether the seroconversion rate is above 90% using a two-dose Sabin IPV alone schedule with the first dose Sabin IPV given at 4 months and the second dose Sabin IPV given ≥4 months after the first dose.'}], 'secondaryOutcomes': [{'measure': 'Neutralizing antibody titers', 'timeFrame': '10 months', 'description': 'Measure neutralizing antibody titers against poliovirus type I, II and III among two-dose Sabin IPV-only schedules compared with three-dose Sabin IPV alone schedule.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inactivated Poliovirus Vaccine', 'Sabin strain'], 'conditions': ['Poliomyelitis']}, 'descriptionModule': {'briefSummary': 'This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.\n\nThe overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.', 'detailedDescription': "In April 2017, WHO/SAGE recommended that a two-dose, IPV-only schedule can be used after polio eradication, with a schedule seroconversion target of at least 90%. The recommendation was based in part on a study conducted in Cuba using Salk-IPV at 4 months and 8 months of age. However, for domestic Sabin IPVs, there are no such data to support a 2-dose schedule among Chinese infants.Two Sabin IPV products that are available to China's National Immunization Program - produced by Kunming Bio institute and China National Biotec Group (CNBG).The monitoring study on sIPV produced by Kunming Bio institute has already applied for approval.This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.\n\nThe overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.\n\nThe specific objectives of the study are to:\n\n1. Determine whether the seroconversion rate is above 90% with a 2-dose Sabin IPV schedule, with the first dose given at 4 months and the second dose given ≥4 months after the first dose.\n2. Measure neutralizing antibody titers against poliovirus type I, II and III among two-dose Sabin IPV alone schedule, compared with three-dose Sabin IPV alone schedule."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent or legal guardian agree to participate in our study.\n* The family is living locally with legal residency status.\n\nExclusion Criteria:\n\n* Parent or legal guardian does not agree to participate in our study.\n* The potential subject has received IPV or OPV before 4 months of age in the two-dose schedule group.\n* The potential subject has one or more contraindications to IPV (although we will note the contraindications).'}, 'identificationModule': {'nctId': 'NCT03546634', 'briefTitle': 'Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Centers for Disease Control and Prevention, China'}, 'officialTitle': 'Sero-conversion Study for a Two-dose Schedule of Sabin Strain Inactivated Poliovirus Vaccine in China', 'orgStudyIdInfo': {'id': '201806'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Three-dose schedule for Sabin IPV', 'description': 'Subjects vaccinate Sabin IPV at 2, 3, and 4 months of age,will be collected blood specimens twice - right before the first dose of IPV, and one month after the 3rd dose of IPV.', 'interventionNames': ['Biological: Sabin IPV']}, {'type': 'EXPERIMENTAL', 'label': 'Two-dose schedule for Sabin IPV', 'description': 'Subjects first dose IPV vaccinate at 4 months of age, and the second dose IPV given between 8 and 11 months of age,will be collected blood specimens twice - right before the first dose of IPV, and one month after the 2nd dose of IPV.', 'interventionNames': ['Biological: Sabin IPV']}], 'interventions': [{'name': 'Sabin IPV', 'type': 'BIOLOGICAL', 'otherNames': ['Sabin strain Inactivated Poliovirus Vaccine'], 'description': "We select one Sabin IPV product, produced by China National Biotec Group, which is available for China's National Immunization Program in the selected study sites.", 'armGroupLabels': ['Three-dose schedule for Sabin IPV', 'Two-dose schedule for Sabin IPV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'country': 'China', 'facility': 'Shandong Center for Disease Control and Prevention', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Zijian Feng', 'role': 'STUDY_CHAIR', 'affiliation': 'Centers for Disease Control and Prevention, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention, China', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Shandong Province Centers for Disease Control and Prevention', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Vaccine Evaluation Division, National Immunization Program', 'investigatorFullName': 'AN Zhijie', 'investigatorAffiliation': 'Centers for Disease Control and Prevention, China'}}}}