{
  "FullStudy":{
    "Rank":218223,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511133",
          "OrgStudyIdInfo":{
            "OrgStudyId":"114444"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"444563/022",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"GSK"
              },{
                "SecondaryId":"444563/033",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"GSK"
              },{
                "SecondaryId":"103477",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"GSK"
              },{
                "SecondaryId":"104480",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"GSK"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"GlaxoSmithKline",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™",
          "OfficialTitle":"Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in the Stool of Infants Aged 6 to 12 Weeks Following Administration of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (444563)"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"April 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2010",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2010",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 1, 2011",
          "StudyFirstSubmitQCDate":"January 12, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 15, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 16, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"GlaxoSmithKline",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"This study aims to test the clinical samples (stool and serum) previously collected during clinical development of HRV vaccine, to identify if there is any evidence of PCV-1 replication and/or immune response to the PCV-1 in vaccinated infants.",
          "DetailedDescription":"Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Rotavirus Infection",
              "Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Laboratory evaluations",
              "infants",
              "Porcine circovirus type 1 (PCV-1)",
              "serologic response",
              "human rotavirus (HRV) vaccine"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Other"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Retrospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Serum and stool samples"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"1",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"HRV Group",
                "ArmGroupDescription":"Subjects received two or three doses of HRV in previous studies.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Stool sample",
                    "Procedure: Serum sample"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo Group",
                "ArmGroupDescription":"Subjects received two or three doses of placebo in previous studies.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Stool sample",
                    "Procedure: Serum sample"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Stool sample",
                "InterventionDescription":"Stool samples collected at pre-determined time points in previous studies will be analysed to detect the presence of PCV-1 DNA and pattern of detection.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "HRV Group",
                    "Placebo Group"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"Serum sample",
                "InterventionDescription":"Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "HRV Group",
                    "Placebo Group"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Presence of PCV-1 DNA and pattern of detection in the stool samples collected",
                "PrimaryOutcomeTimeFrame":"At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)"
              },{
                "PrimaryOutcomeMeasure":"Presence of serum anti-PCV-1 antibody",
                "PrimaryOutcomeTimeFrame":"At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion criteria:\n\nSubjects enrolled previously in randomized, double-blind and placebo-controlled studies 444563/022 (NCT00263666), 444563/033 (NCT00757770), 103477 (NCT00169455), and 104480 (NCT00137930);\nInfants aged 6 to 12 weeks at Dose 1 vaccinated with either HRV vaccine or placebo;\nInfants for whom sufficient residual volume of the stool samples at predetermined time points is available;\nInfants for whom sufficient residual volume of the pre and post vaccination blood samples is available.\n\nExclusion criteria:\n\n- Not applicable",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"6 Weeks",
          "MaximumAge":"12 Weeks",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          },
          "StudyPopulation":"Infants aged 6 to 12 weeks from 4 previously conducted clinical trials, who received 2 or 3 doses of either Rotarix™ or Placebo",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"GSK Clinical Trials",
                "OverallOfficialAffiliation":"GlaxoSmithKline",
                "OverallOfficialRole":"Study Director"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"27657348",
                "ReferenceType":"derived",
                "ReferenceCitation":"Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix™: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012400",
                "ConditionMeshTerm":"Rotavirus Infections"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012088",
                "ConditionAncestorTerm":"Reoviridae Infections"
              },{
                "ConditionAncestorId":"D000012327",
                "ConditionAncestorTerm":"RNA Virus Infections"
              },{
                "ConditionAncestorId":"D000014777",
                "ConditionAncestorTerm":"Virus Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13803",
                "ConditionBrowseLeafName":"Rotavirus Infections",
                "ConditionBrowseLeafAsFound":"Rotavirus Infections",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16105",
                "ConditionBrowseLeafName":"Virus Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13732",
                "ConditionBrowseLeafName":"RNA Virus Infections",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC02",
                "ConditionBrowseBranchName":"Viral Diseases"
              }
            ]
          }
        }
      }
    }
  }
}