{
  "FullStudy":{
    "Rank":217760,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517191",
          "OrgStudyIdInfo":{
            "OrgStudyId":"SOS-VE01"
          },
          "Organization":{
            "OrgFullName":"Dalhousie University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults",
          "OfficialTitle":"Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults",
          "Acronym":"SOS-VE01"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2018",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2016",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2016",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 28, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 30, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Dalhousie University",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Public Health Agency of Canada (PHAC)",
                "CollaboratorClass":"OTHER_GOV"
              },{
                "CollaboratorName":"Canadian Institutes of Health Research (CIHR)",
                "CollaboratorClass":"OTHER_GOV"
              },{
                "CollaboratorName":"GlaxoSmithKline",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This surveillance study will include all consenting adults hospitalized with influenza (cases) at the SOS network of hospitals as well as influenza negative patients(controls), to assess vaccine effectiveness in each group. Both groups will be followed throughout their hospitalization and for 30 days post discharge to monitor severity of illness and outcomes following their illness.",
          "DetailedDescription":"The Canadian Immunization Research Network(CIRN) is a collaborative research network which brings together over 100 investigators in over 40 institutions to evaluate all factors relevant to the introduction of a pandemic influenza vaccine in Canada. The Serious Outcomes Surveillance (SOS) Network within CIRN was established in 2009 to plan for evaluation of influenza vaccine safety and effectiveness. Vaccine effectiveness studies are critical in assessing vaccine effectiveness under real world conditions and in assessing vaccine effectiveness in the prevention of severe outcomes. Establishing the methodology and infrastructure for real-time field assessment of vaccine effectiveness is crucial to inform policy recommendations for the optimal use of resources, including vaccines.\n\nThis study will include all consenting adult patients hospitalized at one of the SOS Network hospitals during influenza season who test positive for influenza (cases). In addition two influenza negative controls will be matched to each case to measure differences in vaccine effectiveness. Specific study aims are:\n\nTo determine the effectiveness of trivalent influenza vaccination (TIV in general, and GSK TIV in particular) in preventing influenza-associated hospitalization in adults ≥ 65 years,\nTo determine the effectiveness of influenza vaccination in preventing influenza-associated death in adults ≥ 65 years\nTo determine the effectiveness of influenza vaccination in preventing influenza-associated hospitalization and death in adults < 65 years\nTo characterize the burden of disease, clinical outcomes, and resource utilization associated with influenza A and influenza B lineages\nTo examine clinical and immunologic factors impacting on severity of disease and influenza vaccine effectiveness in adults"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Influenza"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Influenza",
              "Respiratory Infection"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples Without DNA",
            "BioSpecDescription":"Serum and Nasopharyngeal swabs"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"4197",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Influenza Positive Case",
                "ArmGroupDescription":"Influenza cases are hospitalized adults who have tested positive for influenza."
              },{
                "ArmGroupLabel":"Influenza Negative Control",
                "ArmGroupDescription":"Control Controls are hospitalized adults who have tested negative for influenza."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Estimate the burden of influenza disease and influenza vaccine effectiveness.",
                "PrimaryOutcomeDescription":"Occurrence of any PCR-confirmed influenza virus infection in vaccinated (>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 65 years of age.",
                "PrimaryOutcomeTimeFrame":"1 Year"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Estimate the burden of influenza disease and influenza vaccine effectiveness.",
                "SecondaryOutcomeDescription":"Occurrence of any PCR-confirmed influenza virus infection in vaccinated (>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 16 years of age",
                "SecondaryOutcomeTimeFrame":"1 Year"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAdult patients ≥ 16 years of age admitted to participating SOS Network hospitals with the following admitting diagnoses will be eligible for screening:\npneumonia\nacute exacerbation of chronic obstructive pulmonary disease (AECOPD) or asthma\nunexplained sepsis\nAny other respiratory infection or diagnosis Or any respiratory or influenza-like symptom )(eg dyspnea, cough, sore throat, myalgia, arthralgia, fever, delirium/altered level of consciousness, CHF)\n\nExclusion Criteria:\n\nPatients whose reason for admission was clearly unrelated to the presence of influenza (for example, patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not respiratory,, e.g. cellulitis, intra-abdominal process, or gastrointestinal bleeding) Unless being enrolled as a nosocomial influenza case\nPatients whose onset of symptoms was prior to or within 72 hours of hospital admission but who were not tested for influenza within 7 days of hospital admission. These should be captured on the screening form as screen failures.\nNo children in care will be enrolled in the study",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"16 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"This observational study is open to adults admitted to hospital with test postitive influenza or with an influenza like illness who test negative.",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Shelly A McNeil, MD",
                "OverallOfficialAffiliation":"Dalhousie University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Vancouver General",
                "LocationCity":"Vancouver",
                "LocationState":"British Columbia",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"The Moncton Hospital",
                "LocationCity":"Moncton",
                "LocationState":"New Brunswick",
                "LocationZip":"E1C 6Z8",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"Saint John Regional Hospital",
                "LocationCity":"Saint John",
                "LocationState":"New Brunswick",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"QEII Health Science Centre",
                "LocationCity":"Halifax",
                "LocationState":"Nova Scotia",
                "LocationZip":"B3K 6R8",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"William Osler Health Center",
                "LocationCity":"Brampton",
                "LocationState":"Ontario",
                "LocationZip":"L6R 3J7",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"McMaster",
                "LocationCity":"Hamilton",
                "LocationState":"Ontario",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"Ottawa General",
                "LocationCity":"Ottawa",
                "LocationState":"Ontario",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"Advanced Medical Research Institue of Canada",
                "LocationCity":"Sudbury",
                "LocationState":"Ontario",
                "LocationZip":"P3E 5J1",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"North York General Hospital",
                "LocationCity":"Toronto",
                "LocationState":"Ontario",
                "LocationZip":"M2K 1E1",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"Toronto East General Hospital",
                "LocationCity":"Toronto",
                "LocationState":"Ontario",
                "LocationZip":"M4C 3E7",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"Mount Sinai",
                "LocationCity":"Toronto",
                "LocationState":"Ontario",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"MUCH",
                "LocationCity":"Montreal",
                "LocationState":"Quebec",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"CHUS",
                "LocationCity":"Sherbrooke",
                "LocationState":"Quebec",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"CHUl/CHUQ",
                "LocationCity":"Quebec",
                "LocationZip":"Canada",
                "LocationCountry":"Canada"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"31264957",
                "ReferenceType":"derived",
                "ReferenceCitation":"LeBlanc JJ, ElSherif M, Mulpuru S, Warhuus M, Ambrose A, Andrew M, Boivin G, Bowie W, Chit A, Dos Santos G, Green K, Halperin SA, Hatchette TF, Ibarguchi B, Johnstone J, Katz K, Langley JM, Lagacé-Wiens P, Loeb M, Lund A, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Poirier A, Powis J, Richardson D, Semret M, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA. Validation of the Seegene RV15 multiplex PCR for the detection of influenza A subtypes and influenza B lineages during national influenza surveillance in hospitalized adults. J Med Microbiol. 2020 Feb;69(2):256-264. doi: 10.1099/jmm.0.001032. Epub 2019 Jun 28."
              },{
                "ReferencePMID":"30616737",
                "ReferenceType":"derived",
                "ReferenceCitation":"Mulpuru S, Li L, Ye L, Hatchette T, Andrew MK, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Powis J, Richardson D, Semret M, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN). Effectiveness of Influenza Vaccination on Hospitalizations and Risk Factors for Severe Outcomes in Hospitalized Patients With COPD. Chest. 2019 Jan;155(1):69-78. doi: 10.1016/j.chest.2018.10.044."
              },{
                "ReferencePMID":"30508064",
                "ReferenceType":"derived",
                "ReferenceCitation":"Nichols MK, Andrew MK, Ye L, Hatchette TF, Ambrose A, Boivin G, Bowie W, Dos Santos G, Elsherif M, Green K, Haguinet F, Katz K, Leblanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Powis J, Richardson D, Semret M, Sharma R, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN). The Impact of Prior Season Vaccination on Subsequent Influenza Vaccine Effectiveness to Prevent Influenza-related Hospitalizations Over 4 Influenza Seasons in Canada. Clin Infect Dis. 2019 Aug 30;69(6):970-979. doi: 10.1093/cid/ciy1009."
              },{
                "ReferencePMID":"29548608",
                "ReferenceType":"derived",
                "ReferenceCitation":"Nichols MK, Andrew MK, Hatchette TF, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Lagacé-Wiens P, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Poirier A, Powis J, Richardson D, Schuind A, Semret M, Shinde V, Smith S, Smyth D, Stiver G, Taylor G, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA; Serious Outcomes Surveillance Network of the Canadian Immunization Research Network (CIRN), the Toronto Invasive Bacterial Diseases Network (TIBDN). Influenza vaccine effectiveness to prevent influenza-related hospitalizations and serious outcomes in Canadian adults over the 2011/12 through 2013/14 influenza seasons: A pooled analysis from the Canadian Immunization Research Network (CIRN) Serious Outcomes Surveillance (SOS Network). Vaccine. 2018 Apr 12;36(16):2166-2175. doi: 10.1016/j.vaccine.2018.02.093. Epub 2018 Mar 13."
              },{
                "ReferencePMID":"29284435",
                "ReferenceType":"derived",
                "ReferenceCitation":"Andrew MK, Shinde V, Hatchette T, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney J, McGeer A, Nichols MK, Powis J, Richardson D, Semret M, Stiver G, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Serious Outcomes Surveillance Network and the Toronto Invasive Bacterial Diseases Network (TIBDN). Influenza vaccine effectiveness against influenza-related hospitalization during a season with mixed outbreaks of four influenza viruses: a test-negative case-control study in adults in Canada. BMC Infect Dis. 2017 Dec 29;17(1):805. doi: 10.1186/s12879-017-2905-8."
              },{
                "ReferencePMID":"28931244",
                "ReferenceType":"derived",
                "ReferenceCitation":"Andrew MK, Shinde V, Ye L, Hatchette T, Haguinet F, Dos Santos G, McElhaney JE, Ambrose A, Boivin G, Bowie W, Chit A, ElSherif M, Green K, Halperin S, Ibarguchi B, Johnstone J, Katz K, Langley J, Leblanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McGeer A, Powis J, Richardson D, Semret M, Stiver G, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance Network of the Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) and the Toronto Invasive Bacterial Diseases Network (TIBDN). The Importance of Frailty in the Assessment of Influenza Vaccine Effectiveness Against Influenza-Related Hospitalization in Elderly People. J Infect Dis. 2017 Aug 15;216(4):405-414. doi: 10.1093/infdis/jix282."
              }
            ]
          }
        }
      },
      "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":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13561",
                "ConditionBrowseLeafName":"Respiratory Tract Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8878",
                "ConditionBrowseLeafName":"Influenza, Human",
                "ConditionBrowseLeafAsFound":"Influenza",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M11485",
                "ConditionBrowseLeafName":"Orthomyxoviridae Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16105",
                "ConditionBrowseLeafName":"Virus Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13732",
                "ConditionBrowseLeafName":"RNA Virus Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC08",
                "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC02",
                "ConditionBrowseBranchName":"Viral Diseases"
              }
            ]
          }
        }
      }
    }
  }
}