[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611436":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":56,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"H5N1 vaccine","ACTIVE_COMPARATOR","This arm will receive 2 doses of approved H5N1 vaccine, 3 weeks apart",[13],"Biological: H5N1 vaccine (Arepanrix, GSK)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","This arm will receive 2 doses of normal saline (placebo), 3 weeks apart",[19],"Biological: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","H5N1 vaccine (Arepanrix, GSK)","2 doses of H5N1 vaccine, 3 weeks apart, given IM (deltoid)",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"2 doses of 0.5mls normal saline, 3 weeks apart, given IM (deltoid)",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Victoria G Hall, MBBS MPH","CONTACT","1 416 340 4800","victoria.hall@uhn.ca",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University Health Network","RECRUITING","Toronto","Ontario","M5G2N2","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-79.39864,43.70643,{"lat":49,"lon":48},[52,54],{"name":32,"role":33,"phone":53,"phoneExt":26,"email":35},"4163404800",{"name":32,"role":55,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Victoria Hall","Dr Victoria Hall, Principal Investigator, Clinician-Investigator and Infectious Diseases physician",[60],{"name":61,"class":6},"Laval University","100611436","phase-3-pandemic-influenza-vaccine-in-organ-transplantation-pivot-trial-100611436",false,"NCT07240558","Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)","Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial): Safety and Immunogenicity of Pandemic Influenza Vaccine in Organ Transplant Recipients","PIVOT","Inclusion Criteria:\n\n* Age ≥ 18 and greater than 3 months post-transplant\n* Stable graft function\n* eGFR \\>30mL\u002Fmin\u002F1.73m2\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Allergy to vaccine components;\n* Previous life-threatening reaction to influenza vaccine (ie Guillain Barré Syndrome);\n* Ongoing or recent therapy for acute rejection (within the previous 30 days);\n* Ongoing active cytomegalovirus (CMV) infection with viral load of greater or equal to 1000 international units\u002Fml in the last 7 days;\n* Febrile illness in the past 2 weeks;\n* Rituximab in the last 6 months;\n* Receiving treatment for active or acute infection;\n* Unable to provide informed consent;\n* 2025 seasonal influenza vaccination in preceding 6 weeks;\n* Recent other vaccination in last 14 days;\n* Receipt of intravenous immunoglobulin in last 30 days or expected to receive in next 30 days; Life expectancy \\\u003C 3 months;\n* Diagnosis of influenza virus infection in the last 90 days.\n* Pregnancy known at the time of enrolment","ALL","18 Years",{"count":73,"type":74},120,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","Influenza is an important pathogen in transplant recipients. The current widespread outbreak of highly pathogenic H5N1 avian influenza (HPAI) in livestock, and the occurrence of several human cases of infection suggest that the next influenza pandemic may be soon approaching. Transplant patients will likely be uniquely predisposed to serious infection with high morbidity and mortality. There are a number of important reasons that evaluation of prevention strategies are critical in this highly vulnerable population. Currently, there is no data on the immunogenicity of H5Nx vaccines in this highly vulnerable population. The investigators plan to study the safety and immunogenicity of a two-dose regimen of the pandemic influenza H5N1 vaccine in organ transplant patients.",[80,81,82],"Influenza (Pandemic)","Avian Influenza","Vaccination","2025-12-11",{"date":85,"type":86},"2025-12-18","ACTUAL",{"date":88,"type":86},"2025-11-03",{"date":90,"type":74},"2026-12-31",{"name":5,"class":6},1]