{
  "FullStudy":{
    "Rank":218280,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510366",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IMBCAMS-03"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2011L01484",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"China state food and drug adminstration"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Chinese Academy of Medical Sciences",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)",
          "OfficialTitle":"The Phase Ⅲ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains",
          "Acronym":"IPV"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 6, 2012",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 13, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 15, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Guoyang Liao",
            "ResponsiblePartyInvestigatorTitle":"Head of Biologicals No.5",
            "ResponsiblePartyInvestigatorAffiliation":"Chinese Academy of Medical Sciences"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Chinese Academy of Medical Sciences",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Guangxi Center for Disease Control and Prevention",
                "CollaboratorClass":"OTHER_GOV"
              },{
                "CollaboratorName":"National Institute for the Control of Pharmaceutical and Biological Products, China",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "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."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Poliomyelitis"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Inactivated Poliomyelitis Vaccine",
              "Sabin Strains",
              "poliomyelitis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"1200",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Cohort 1",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)"
                  ]
                }
              },{
                "ArmGroupLabel":"Cohort 2:",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: Inactivated Poliomyelitis Vaccine (Salk strains)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Biological",
                "InterventionName":"Inactivated Poliomyelitis Vaccine (Sabin strains)",
                "InterventionDescription":"Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Cohort 1"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Sabin IPV"
                  ]
                }
              },{
                "InterventionType":"Biological",
                "InterventionName":"Inactivated Poliomyelitis Vaccine (Salk strains)",
                "InterventionDescription":"Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Cohort 2:"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Salk IPV or cIPV"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants",
                "PrimaryOutcomeDescription":"Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.",
                "PrimaryOutcomeTimeFrame":"fours year"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants",
                "SecondaryOutcomeDescription":"Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination",
                "SecondaryOutcomeTimeFrame":"One year"
              },{
                "SecondaryOutcomeMeasure":"Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV",
                "SecondaryOutcomeDescription":"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.",
                "SecondaryOutcomeTimeFrame":"30-60 days after third dose immunization"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMales and females, age from 60 days to 90 days;\nAdults, parent(s) or guardians are able to understand and sign informed consent for participation;\nParticipants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;\nInfants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;\nAxillary temperature ≤37℃.\n\nExclusion Criteria:\n\nHave medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;\nLow platelet or bleeding disorder do not allow vaccination into the muscle;\nHave damaged or lower immunological function;\nReceived blood, plasma or immunoglobulin treatment since birth;\nHave inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );\nHave 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\nHave serious anaphylaxis or high fever, convulsion during first dose;\nHave any circus of Exclusion Criteria after Eligible for study;\nHave serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;\nReceived necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;\nVaccinated with any other vaccine（except DTP）;\nStop observation determined by investigator owing to occurring serious adverse event.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"60 Days",
          "MaximumAge":"90 Days",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Guoyang Liao, PH.D",
                "OverallOfficialAffiliation":"Chinese Academy of Medical Sciences",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Yanping Li, MD",
                "OverallOfficialAffiliation":"Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Changgui Li, PHD",
                "OverallOfficialAffiliation":"National Institute for the Control of Pharmaceutical and Biological Products, China",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Pingle Center for Disease Prevention and Control",
                "LocationCity":"Guilin",
                "LocationState":"Guangxi",
                "LocationZip":"530400",
                "LocationCountry":"China"
              },{
                "LocationFacility":"Bingyang Center for Disease Prevention and Control",
                "LocationCity":"Nanning",
                "LocationState":"Guangxi",
                "LocationZip":"530400",
                "LocationCountry":"China"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000014612",
                "InterventionMeshTerm":"Vaccines"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000007155",
                "InterventionAncestorTerm":"Immunologic Factors"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M15943",
                "InterventionBrowseLeafName":"Vaccines",
                "InterventionBrowseLeafAsFound":"Vaccine",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8784",
                "InterventionBrowseLeafName":"Immunologic Factors",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000011051",
                "ConditionMeshTerm":"Poliomyelitis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000004769",
                "ConditionAncestorTerm":"Enterovirus Infections"
              },{
                "ConditionAncestorId":"D000010850",
                "ConditionAncestorTerm":"Picornaviridae Infections"
              },{
                "ConditionAncestorId":"D000012327",
                "ConditionAncestorTerm":"RNA Virus Infections"
              },{
                "ConditionAncestorId":"D000014777",
                "ConditionAncestorTerm":"Virus Diseases"
              },{
                "ConditionAncestorId":"D000009187",
                "ConditionAncestorTerm":"Myelitis"
              },{
                "ConditionAncestorId":"D000002494",
                "ConditionAncestorTerm":"Central Nervous System Infections"
              },{
                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000013118",
                "ConditionAncestorTerm":"Spinal Cord Diseases"
              },{
                "ConditionAncestorId":"D000009468",
                "ConditionAncestorTerm":"Neuromuscular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M12522",
                "ConditionBrowseLeafName":"Poliomyelitis",
                "ConditionBrowseLeafAsFound":"Poliomyelitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6513",
                "ConditionBrowseLeafName":"Enterovirus Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12328",
                "ConditionBrowseLeafName":"Picornaviridae Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16105",
                "ConditionBrowseLeafName":"Virus Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13732",
                "ConditionBrowseLeafName":"RNA Virus Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10725",
                "ConditionBrowseLeafName":"Myelitis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4326",
                "ConditionBrowseLeafName":"Central Nervous System Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14498",
                "ConditionBrowseLeafName":"Spinal Cord Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10994",
                "ConditionBrowseLeafName":"Neuromuscular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T4633",
                "ConditionBrowseLeafName":"Poliomyelitis",
                "ConditionBrowseLeafAsFound":"Poliomyelitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T4013",
                "ConditionBrowseLeafName":"Myelitis",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC02",
                "ConditionBrowseBranchName":"Viral Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}