Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT01056705
Status:
COMPLETED
Last Update Posted:
2016-08-02
First Post:
2010-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (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'}, {'id': 'D011055', 'term': 'Poliovirus Vaccine, Oral'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-31', 'studyFirstSubmitDate': '2010-01-25', 'studyFirstSubmitQcDate': '2010-01-25', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does on Healthy infants .', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Inactivated Poliomyelitis Vaccine', 'Sabin Strains', 'poliomyelitis'], 'conditions': ['Poliomyelitis']}, 'referencesModule': {'references': [{'pmid': '28419204', 'type': 'DERIVED', 'citation': 'Sun M, Li C, Xu W, Liao G, Li R, Zhou J, Li Y, Cai W, Yan D, Che Y, Ying Z, Wang J, Yang H, Ma Y, Ma L, Ji G, Shi L, Jiang S, Li Q. Immune Serum From Sabin Inactivated Poliovirus Vaccine Immunization Neutralizes Multiple Individual Wild and Vaccine-Derived Polioviruses. Clin Infect Dis. 2017 May 15;64(10):1317-1325. doi: 10.1093/cid/cix110.'}, {'pmid': '22158682', 'type': 'DERIVED', 'citation': 'Liao G, Li R, Li C, Sun M, Li Y, Chu J, Jiang S, Li Q. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, positive-controlled trial. J Infect Dis. 2012 Jan 15;205(2):237-43. doi: 10.1093/infdis/jir723. Epub 2011 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of phase Ⅱ 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 type1, 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. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.\n\nOral Poliomyelitis Vaccine(OPV)was manufactured by Institute of Medical Biology, Chinese Academy of Medical Sciences.Trivalent OPV contains Polioviruses Type 1 6.0 log CCID Type 2 5.0 log Type 3 5.5log /0.1ml/per dose Inactivated Poliomyelitis Vaccine (Salk strains)was manufactured by Sanofi Pasteur DAg contents /0.5ml/per dose were Type 1 40 DU,Type 2 8DU,Type 3 32DU.\n\nThis is a randomized, blind phase 2 clinical trial. Total 500 infants (ages 60 days to 90 days) were selected , randomized to five groups(each group n=100) Sabin IPV formulations A,B,C,OPV ,Salk IPV were separately given to each group with three doses one month apart respectively.'}, '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': 'NCT01056705', 'acronym': 'Sabin IPV', 'briefTitle': 'The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV)', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'The Phase Ⅱ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains', 'orgStudyIdInfo': {'id': 'imbcams-02'}, 'secondaryIdInfos': [{'id': 'SFDA2007L02021', 'type': 'OTHER', 'domain': 'China state food and drug adminstration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Experiment Infants', 'description': 'Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections;', 'interventionNames': ['Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Experiment infants', 'description': 'Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections;', 'interventionNames': ['Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: Experiment infants', 'description': 'Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections;', 'interventionNames': ['Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: Experiment infants', 'description': 'Biological: Oral Poliomyelitis Vaccine (OPV).3x0.1ml oral;', 'interventionNames': ['Biological: Oral Poliomyelitis Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5: Experiment infants', 'description': 'Biological: Inactivated Poliomyelitis Vaccine (Salk strains). 3x0.5ml 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) formulation A. 3x0.5ml intramuscular injections,one month apart.', 'armGroupLabels': ['Cohort 1: Experiment Infants']}, {'name': 'Inactivated Poliomyelitis Vaccine (Sabin strains)', 'type': 'BIOLOGICAL', 'otherNames': ['Sabin IPV'], 'description': 'Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.', 'armGroupLabels': ['Cohort 2: Experiment infants']}, {'name': 'Inactivated Poliomyelitis Vaccine (Sabin strains)', 'type': 'BIOLOGICAL', 'otherNames': ['Sabin IPV'], 'description': 'Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.', 'armGroupLabels': ['Cohort 3: Experiment infants']}, {'name': 'Oral Poliomyelitis Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['OPV'], 'description': 'Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.', 'armGroupLabels': ['Cohort 4: Experiment infants']}, {'name': 'Inactivated Poliomyelitis Vaccine (Salk strains).', 'type': 'BIOLOGICAL', 'otherNames': ['Salk IPV'], 'description': '3x0.5ml intramuscular injections, one month apart.', 'armGroupLabels': ['Cohort 5: Experiment infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '542400', 'city': 'Pingle County', 'state': 'Guangxi', 'country': 'China', 'facility': 'Pingle Center for Disease Control and Prevention'}], 'overallOfficials': [{'name': 'Liao Guoyang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Medical Biology, Chinese Academy of Medical Sciences'}, {'name': 'Li Rongcheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control'}, {'name': 'Li Changgui, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute for the Control of Pharmaceutical and Biological Products, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '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': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Biologicals No.5', 'investigatorFullName': 'Guoyang Liao', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}