Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-10 @ 12:43 PM
Study NCT ID:
NCT02231632
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2014-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-07', 'studyFirstSubmitDate': '2014-08-01', 'studyFirstSubmitQcDate': '2014-09-01', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated', 'timeFrame': 'up to 90 days', 'description': '20 children aged 4 years old and 20 infants aged 2 months were vaccinated with 3 dose of Live attenuated Poliomyelitis vaccine (human diploid cell). Their faeces on day 0,7,30,60 and 90 were collected and incubated in L20B and RD cells for 2 generations, in order to separate and amplify poliovirus I-III Sabin strains in faeces of study objects . Extract total viral RNA from the culture supernatants and detect virogene VP1 through RT-PCR and sequencing ,in order to test the genovariation of vaccinal I-III Sabin strains in faeces after vaccinated .'}], 'secondaryOutcomes': [{'measure': 'The frequency of all the adverse events in vaccine group and placebo group', 'timeFrame': 'up to 30 days', 'description': 'compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine groups.'}, {'measure': 'Change of seroconversion from baseline to 3 months', 'timeFrame': 'up to 3 months', 'description': 'Randomly chose 600 infants respectively from two study arms, get 2.5ml of the blood on the first day and 3 months during vaccination .Reciprocal antibody titers of at least 1:8, the lowest detectable titer, is considered to indicate seropositivity with regards to the presence of poliovirus neutralizing antibodies. Seroconversion is defined as either seronegative participants (\\<1:8 titers) who become seropositive (≥1:8) or participants who demonstrate a 4-fold change in titers between two specimens, e.g. a change from 1:8 to 1:32. Chi-square tests will be used to test the statistical significance among seroconversion rates across study arms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Poliomyelitis', 'Vaccine', 'Safety', 'efficacy'], 'conditions': ['Poliomyelitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell)', 'detailedDescription': 'Live attenuated Poliomyelitis vaccine (human diploid cell) is used for poliovirus prevention in children above 2 years old , Which was developed by Institute of Medical Biology , Chinese Academy of Medical Sciences , based on the other two products : Poliomyelitis Vaccine in Dragee Candy (Monkey Kidney Cell), Live ; and Poliomyelitis（Live）Vaccine (Monkey Kidney Cell),Oral . After its safety been proved in phase 1 clinical trail evaluation , the phase 2/3 trail was started in Guangxi Province, China during 2011-2012. The purpose of this trial is to assess the safety and immunogenicity in healthy children of 2,3 and 4 months old .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:Only subjects fulfilling all of the following criteria will be eligible for the study:\n\n* People aged from 2 months to 4 months old.\n* The subjects or subjects' guardians are able to understand and sign the informed consent\n* The subjects or subjects' guardians allow to comply with the requirements of the protocol\n* Subjects with temperature \\<=37.0°C on axillary setting\n* The subjects have signed informed consent already\n\nExclusion Criteria:The subjects have never been vaccinated with any Poliomyelitis Vaccine.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT02231632', 'briefTitle': 'The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Medical Biology, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Phase 2/3 Clinical Trial to Assess the Safety and Immunogenicity of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)', 'orgStudyIdInfo': {'id': 'Yangjingsi2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Live attenuated Poliomyelitis vaccine (human diploid cell)', 'description': '6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).', 'interventionNames': ['Biological: Live attenuated Poliomyelitis vaccine (Human Diploid Cell)']}, {'type': 'EXPERIMENTAL', 'label': 'Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral', 'description': '6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).', 'interventionNames': ['Biological: Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)']}], 'interventions': [{'name': 'Live attenuated Poliomyelitis vaccine (Human Diploid Cell)', 'type': 'BIOLOGICAL', 'otherNames': ['Poliomyelitis（Live）Vaccine(Human Diploid Cell),Oral'], 'description': "6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).", 'armGroupLabels': ['Live attenuated Poliomyelitis vaccine (human diploid cell)']}, {'name': 'Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)', 'type': 'BIOLOGICAL', 'otherNames': ['Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral'], 'description': "6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).", 'armGroupLabels': ['Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650118', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Institute of Medical Biology -Chinese Academy of Medical Sciences Kunming, Yunnan, China 650118', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'overallOfficials': [{'name': 'Qihan Li, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Institude of Medical Biology, Chinese Academy of Medical Sciences'}, {'name': 'Jingsi Yang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institude of Medical Biology, Chinese Academy of Medical Sciences'}, {'name': 'Rongcheng Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangxi Provincial Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Medical Biology, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangxi Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}