{
  "FullStudy":{
    "Rank":218152,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512056",
          "OrgStudyIdInfo":{
            "OrgStudyId":"BR-100-086"
          },
          "Organization":{
            "OrgFullName":"National Cheng-Kung University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients",
          "OfficialTitle":"Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2012",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2012",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"November 1, 2011",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 13, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"National Cheng-Kung University Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).",
          "DetailedDescription":"The immune response to influenza vaccine was poor in dialysis population than general population. The investigators want to evaluate another booster vaccination can improve the immune response in dialysis population. All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). The investigators will collect serum of participants 3 weeks, 6 weeks, 9 weeks and 18 weeks post vaccination and evaluate the difference of immune response in these 3 groups."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Influenza"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Influenza vaccine",
              "dialysis",
              "vaccine",
              "Seroprotection",
              "Seroresponse",
              "Seroconversion",
              "Safety of the vaccine"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"300",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"the immunogenicity profiles of the AdimFlu-S",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Experimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later.\n\nNegative control group: dialysis patients who refused to receive influenza vaccination.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: AdimFlu-S"
                  ]
                }
              },{
                "ArmGroupLabel":"The safety outcome of the vaccine",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"Any adverse effect, including systemic or local site, will be recorded during the study period."
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"AdimFlu-S",
                "InterventionDescription":"All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). Each dose of vaccine contains 15μg antigen of each virus strain suggested by WHO (A/California/7/2009 (H1N1);A/Perth/16/2009 (H3N2);B/Brisbane/60/2008).",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "the immunogenicity profiles of the AdimFlu-S"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change of antibody titer before and after influenza vaccination",
                "PrimaryOutcomeDescription":"The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination. The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.",
                "PrimaryOutcomeTimeFrame":"18 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Seroresponse rate",
                "SecondaryOutcomeDescription":"The seroconversion is defined as the HI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HI serum titer or a four-fold or greater increase in HI titers in subjects who had a positive pre-vaccination HAI serum titer.",
                "SecondaryOutcomeTimeFrame":"0, 3 weeks, 6 weeks, 9 weeks and 18 weeks"
              },{
                "SecondaryOutcomeMeasure":"Seroresponse rate",
                "SecondaryOutcomeDescription":"The seroresponse is defined as HI or micro-NT titer of the post-vaccination serum is at least 4-fold increase of the HI or micro-NT titer after vaccination.\n\nGeometric mean folds increase in HI or micro-NT titer.",
                "SecondaryOutcomeTimeFrame":"0, 3 weeks, 6 weeks, 9 weeks and 18 weeks"
              },{
                "SecondaryOutcomeMeasure":"the safety and tolerability profiles of the vaccine",
                "SecondaryOutcomeDescription":"evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation.",
                "SecondaryOutcomeTimeFrame":"0, 3 week, 6 weeks, 9 weeks, 18 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMales and non-pregnant females and aged more than 18 years;\nWilling and able to adhere to visit schedules and all study requirements;\nSubjects read and signed the study-specific informed consent.\n\nExclusion Criteria:\n\nSubject or his/her family is employed by the participated hospital;\nSubjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;\nHistory of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;\nPersonal or family history of Guillain-Barré Syndrome;\nAn acute febrile illness within 1 week prior to vaccination;\nCurrent upper respiratory illness, including the common cold or nasal congestion within 72 hours;\nSubjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;\nFemale subjects who are pregnant during the study.\nPatients who receive hemodialysis therapy less than 3 months.\nTreatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;\nImmunodeficiency, or under immunosuppressive treatment.\nReceipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);\nReceipt of any blood products, including immunoglobulin in the prior 3 months;\nAny severe illness needed to be hospitalization within three months.\nUnderlying condition in the investigators' opinion may interfere with evaluation of the vaccine.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Junne Ming Sung, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"886-6-2353535",
                "CentralContactPhoneExt":"2594",
                "CentralContactEMail":"jmsung@mail.ncku.edu.tw"
              },{
                "CentralContactName":"Yu Tzu Chang, MD and Msc",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"886-6-2353535",
                "CentralContactPhoneExt":"2593",
                "CentralContactEMail":"kangxiemperor@gmail.com"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"National Cheng Kung University Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Tainan",
                "LocationZip":"704",
                "LocationCountry":"Taiwan",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Junne Ming Sung, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"886-6-2353535",
                      "LocationContactPhoneExt":"2594",
                      "LocationContactEMail":"jmsung@mail.ncku.edu.tw"
                    },{
                      "LocationContactName":"Yu Tzu Chang, MD and Msc",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"886-6-2353535",
                      "LocationContactPhoneExt":"2593",
                      "LocationContactEMail":"kangxiemperor@gmail.com"
                    },{
                      "LocationContactName":"Junne Ming Sung, MD",
                      "LocationContactRole":"Principal Investigator"
                    },{
                      "LocationContactName":"Yu Tzu Chang, MD and Msc",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Yi Ching Yang, MD",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Meng Te Lin, MD",
                      "LocationContactRole":"Sub-Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007251",
                "ConditionMeshTerm":"Influenza, Human"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009976",
                "ConditionAncestorTerm":"Orthomyxoviridae Infections"
              },{
                "ConditionAncestorId":"D000012327",
                "ConditionAncestorTerm":"RNA Virus Infections"
              },{
                "ConditionAncestorId":"D000014777",
                "ConditionAncestorTerm":"Virus Diseases"
              },{
                "ConditionAncestorId":"D000012141",
                "ConditionAncestorTerm":"Respiratory Tract Infections"
              },{
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8878",
                "ConditionBrowseLeafName":"Influenza, Human",
                "ConditionBrowseLeafAsFound":"Influenza",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11485",
                "ConditionBrowseLeafName":"Orthomyxoviridae Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16105",
                "ConditionBrowseLeafName":"Virus Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13732",
                "ConditionBrowseLeafName":"RNA Virus Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13561",
                "ConditionBrowseLeafName":"Respiratory Tract Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC02",
                "ConditionBrowseBranchName":"Viral Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC08",
                "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              }
            ]
          }
        }
      }
    }
  }
}