Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 2:23 PM
Study NCT ID:
NCT01510366
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2012-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011054', 'term': 'Poliovirus Vaccine, Inactivated'}], 'ancestors': [{'id': 'D015164', 'term': 'Vaccines, Inactivated'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D023321', 'term': 'Poliovirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-08', 'studyFirstSubmitDate': '2012-01-06', 'studyFirstSubmitQcDate': '2012-01-11', 'lastUpdatePostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants', 'timeFrame': 'fours year', 'description': 'Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.'}], 'secondaryOutcomes': [{'measure': 'The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants', 'timeFrame': 'One year', 'description': 'Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination'}, {'measure': 'Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV', 'timeFrame': '30-60 days after third dose immunization', 'description': 'One dose of tOPV was given after one month of third dose of IPV. The stool specimens were obtained at 0, 7, 14, 21, 28 days after OPV challenge. And determine the excretion rates of polioviruses.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inactivated Poliomyelitis Vaccine', 'Sabin Strains', 'poliomyelitis'], 'conditions': ['Poliomyelitis']}, 'referencesModule': {'references': [{'pmid': '37745024', 'type': 'DERIVED', 'citation': 'Ma L, Ying Z, Cai W, Wang J, Zhou J, Yang H, Gao J, Zhao Z, Liu J, Ouyang S, Song S, Shen F, Zhao R, Xu L, Dai X, Wu Y, Li W, Li C, Liao G. Immune persistence of an inactivated poliovirus vaccine derived from the Sabin strain: a 10-year follow-up of a phase 3 study. EClinicalMedicine. 2023 Sep 14;64:102151. doi: 10.1016/j.eclinm.2023.102151. eCollection 2023 Oct.'}]}, 'descriptionModule': {'briefSummary': 'Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).', 'detailedDescription': 'The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested, ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.\n\nInactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.\n\nThis is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '90 Days', 'minimumAge': '60 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, age from 60 days to 90 days;\n* Adults, parent(s) or guardians are able to understand and sign informed consent for participation;\n* Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;\n* Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;\n* Axillary temperature ≤37℃.\n\nExclusion Criteria:\n\n* Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;\n* Low platelet or bleeding disorder do not allow vaccination into the muscle;\n* Have damaged or lower immunological function;\n* Received blood, plasma or immunoglobulin treatment since birth;\n* Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );\n* Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.\n\nExclusion Criteria for doses 2 and 3\n\n* Have serious anaphylaxis or high fever, convulsion during first dose;\n* Have any circus of Exclusion Criteria after Eligible for study;\n* Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;\n* Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;\n* Vaccinated with any other vaccine（except DTP）;\n* Stop observation determined by investigator owing to occurring serious adverse event.'}, 'identificationModule': {'nctId': 'NCT01510366', 'acronym': 'IPV', 'briefTitle': 'The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Medical Biology, Chinese Academy of Medical Sciences'}, 'officialTitle': 'The Phase Ⅲ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains', 'orgStudyIdInfo': {'id': 'IMBCAMS-03'}, 'secondaryIdInfos': [{'id': '2011L01484', 'type': 'OTHER', 'domain': 'China state food and drug adminstration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections.', 'interventionNames': ['Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2:', 'description': 'Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections.', 'interventionNames': ['Biological: Inactivated Poliomyelitis Vaccine (Salk strains)']}], 'interventions': [{'name': 'Inactivated Poliomyelitis Vaccine (Sabin strains)', 'type': 'BIOLOGICAL', 'otherNames': ['Sabin IPV'], 'description': 'Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.', 'armGroupLabels': ['Cohort 1']}, {'name': 'Inactivated Poliomyelitis Vaccine (Salk strains)', 'type': 'BIOLOGICAL', 'otherNames': ['Salk IPV or cIPV'], 'description': 'Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.', 'armGroupLabels': ['Cohort 2:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530400', 'city': 'Guilin', 'state': 'Guangxi', 'country': 'China', 'facility': 'Pingle Center for Disease Prevention and Control', 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}, {'zip': '530400', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Bingyang Center for Disease Prevention and Control', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'overallOfficials': [{'name': 'Guoyang Liao, PH.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences'}, {'name': 'Yanping Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control'}, {'name': 'Changgui Li, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute for the Control of Pharmaceutical and Biological Products, China'}]}, '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'}, {'name': 'National Institute for the Control of Pharmaceutical and Biological Products, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}