Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT03147560
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2017-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 528}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'seroconversion rate', 'timeFrame': 'seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.', 'description': 'any positive antibody response in infants who were seronegative prior to their first dose, or at least a fourfold increase in type-specific antibody levels for infants who had pre-existing antibodies.'}], 'secondaryOutcomes': [{'measure': 'safety: rate of adverse events', 'timeFrame': 'At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.', 'description': 'the rate of adverse events.'}, {'measure': 'neutralizing antibody titer', 'timeFrame': 'Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunogenicity', 'Safety', 'Sabin IPV', 'bOPV'], 'conditions': ['Polio']}, 'referencesModule': {'references': [{'pmid': '32442523', 'type': 'DERIVED', 'citation': 'He H, Wang Y, Deng X, Yue C, Tang X, Li Y, Liu Y, Yin Z, Zhang G, Chen Z, Xie S, Wen N, An Z, Chen Z, Wang H. Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial. Lancet Infect Dis. 2020 Sep;20(9):1071-1079. doi: 10.1016/S1473-3099(19)30738-8. Epub 2020 May 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '75 Days', 'minimumAge': '60 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.\n* Participant is aged ≥ 60 days to ≤ 75 days.\n* Participant without preventive inoculation of polio vaccine and previous history of Polio.\n* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.\n* Body temperature ≤ 37.5℃.\n\nExclusion Criteria:\n\n* Known allergy to any constituent of the vaccine.\n* Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.\n* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.\n* Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.\n* Known bleeding disorder.\n* Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.\n* Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.\n* An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial.\n* Participation in any other intervention clinical trial.\n* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.'}, 'identificationModule': {'nctId': 'NCT03147560', 'briefTitle': 'Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zhejiang Provincial Center for Disease Control and Prevention'}, 'officialTitle': 'Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants', 'orgStudyIdInfo': {'id': 'ZJCDC20170508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'The sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV.', 'interventionNames': ['Biological: Sabin IPV+ bOPV+ bOPV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'The sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV.', 'interventionNames': ['Biological: Sabin IPV + Sabin IPV + bOPV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'The sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV.', 'interventionNames': ['Biological: Sabin IPV + Sabin IPV + Sabin IPV']}], 'interventions': [{'name': 'Sabin IPV+ bOPV+ bOPV', 'type': 'BIOLOGICAL', 'description': 'Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.', 'armGroupLabels': ['Group 1']}, {'name': 'Sabin IPV + Sabin IPV + bOPV', 'type': 'BIOLOGICAL', 'description': 'Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.', 'armGroupLabels': ['Group 2']}, {'name': 'Sabin IPV + Sabin IPV + Sabin IPV', 'type': 'BIOLOGICAL', 'description': 'Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Chunan Center for Disease Control and Prevention', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Quzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Longyou Center for Disease Control and Prevention', 'geoPoint': {'lat': 28.95944, 'lon': 118.86861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Provincial Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'China National Biotec Group Company Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}