[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550867":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":173,"collaborators":175,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":53,"eligibilityCriteria":196,"healthyVolunteers":197,"sex":198,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":53,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":70,"whyStopped":53,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},{"fullName":5,"class":6},"Technical University of Munich","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Verum","ACTIVE_COMPARATOR","Comirnaty® 3 µg Omicron XBB.1.5 or future new variant developments replacing current Comirnaty vaccines for children\n\nSuspension for injection, for intramuscular use\n\n1. st dose at age 6.0 to 7.0 months\n2. nd dose at least 3 weeks through to 6 weeks after 1st dose\n3. rd dose at least 8 weeks after 2nd dose (around age 8.5 to 11 months)\n\nDose adjustment in case of COVID-19 infection.",[13],"Drug: Comirnaty Injectable Product",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","0.9 % Sodium Chloride Solution (saline) for intramuscular injection Dosing: three doses\n\n1. st dose at age 6.0 to 7.0 months\n2. nd dose at least 3 weeks through to 6 weeks after 1st dose\n3. rd dose at least 8 weeks after 2nd dose (around age 8.5 to 11 months)",[19],"Drug: Sodium Chloride 0.9% Inj",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Comirnaty Injectable Product","Vaccination",[9],[27],"Comirnaty 3µg\u002Fdose for children for 6 month - 4 years",{"type":22,"name":29,"description":24,"armGroupLabels":30,"otherNames":31},"Sodium Chloride 0.9% Inj",[15],[32],"Solution for Injection",[34],{"name":35,"affiliation":36,"role":37},"Anette-G. Ziegler","Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Anette-G. Ziegler, Prof. Dr.","CONTACT","+49-89-3187","2896","anettegabriele.ziegler@helmholtz-munich.de",{"name":46,"role":41,"phone":42,"phoneExt":43,"email":47},"Peter Achenbach, Prof. Dr.","peter.achenbach@helmholtz-munich.de",[49,68,83,98,111,124,138,151,162],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria","NOT_YET_RECRUITING","Vienna",null,"1090","Austria","AT",{"type":58,"coordinates":59},"Point",[60,61],16.37208,48.20849,{"lat":61,"lon":60},[64],{"name":65,"role":41,"phone":66,"phoneExt":53,"email":67},"Birgit Rami-Merhar, Prof.","+43-1-40400-32320","Birgit.Rami@meduniwien.ac.at",{"facility":69,"status":70,"city":71,"state":53,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":58,"coordinates":76},[77,78],4.70093,50.87959,{"lat":78,"lon":77},[81],{"name":82,"role":41,"phone":53,"phoneExt":53,"email":53},"Kristina Casteels, Prof. Dr.",{"facility":84,"status":70,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich","Munich","Bavaria","80939","Germany","DE",{"type":58,"coordinates":91},[92,93],11.57549,48.13743,{"lat":93,"lon":92},[96],{"name":97,"role":41,"phone":42,"phoneExt":43,"email":44},"Anette-G Ziegler, Prof. Dr.",{"facility":99,"status":70,"city":100,"state":101,"zip":102,"country":88,"countryCode":89,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"AUF DER BULT, Kinder- und Jugendkrankenhaus","Hanover","Lower Saxony","30173",{"type":58,"coordinates":104},[105,106],9.73322,52.37052,{"lat":106,"lon":105},[109],{"name":110,"role":41,"phone":53,"phoneExt":53,"email":53},"Olga Kordonouri, Prof. Dr.",{"facility":112,"status":70,"city":113,"state":114,"zip":115,"country":88,"countryCode":89,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden","Dresden","Saxony","01307",{"type":58,"coordinates":117},[118,119],13.73832,51.05089,{"lat":119,"lon":118},[122],{"name":123,"role":41,"phone":53,"phoneExt":53,"email":53},"Reinhard Berner, Prof.Dr.",{"facility":125,"status":70,"city":126,"state":53,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS","Malmö","20213","Sweden","SE",{"type":58,"coordinates":131},[132,133],13.00073,55.60587,{"lat":133,"lon":132},[136],{"name":137,"role":41,"phone":53,"phoneExt":53,"email":53},"Marcus Lundgren, Dr.",{"facility":139,"status":51,"city":140,"state":53,"zip":53,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Birmingham Women's and Children's NHS Foundation Trust","Birmingham","United Kingdom","UK",{"type":58,"coordinates":144},[145,146],-1.89983,52.48142,{"lat":146,"lon":145},[149],{"name":150,"role":41,"phone":53,"phoneExt":53,"email":53},"Renuka Dias",{"facility":152,"status":51,"city":153,"state":53,"zip":53,"country":141,"countryCode":142,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Cambridge University Hospitals NHS Foundation Trust","Cambridge",{"type":58,"coordinates":155},[156,157],0.11667,52.2,{"lat":157,"lon":156},[160],{"name":161,"role":41,"phone":53,"phoneExt":53,"email":53},"Loredana Marcovecchio, MD, PhD",{"facility":163,"status":70,"city":164,"state":53,"zip":53,"country":141,"countryCode":142,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"The Newcastle upon Tyne Hospitals NHS Foundation Trust","Newcastle",{"type":58,"coordinates":166},[167,168],-5.88979,54.21804,{"lat":168,"lon":167},[171],{"name":172,"role":41,"phone":53,"phoneExt":53,"email":53},"Catherine Owen, PhD",{"type":174,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[176,179,181,183,185,187,189,190],{"name":177,"class":178},"Helmholtz Zentrum München","INDUSTRY",{"name":180,"class":6},"University Hospital Carl Gustav Carus",{"name":182,"class":6},"Kinderkrankenhaus auf der Bult",{"name":184,"class":6},"Skane University Hospital",{"name":186,"class":6},"Universitaire Ziekenhuizen KU Leuven",{"name":188,"class":6},"Newcastle-upon-Tyne Hospitals NHS Trust",{"name":152,"class":6},{"name":139,"class":6},"100550867","phase-4-anti-viral-action-against-type-1-diabetes-autoimmunity-100550867",false,"NCT06452654","Anti-viral Action Against Type 1 Diabetes Autoimmunity","Inclusion Criteria:\n\n1. Ages between 3.00 and 4.00 months at the time of enrollment.\n2. A high genetic risk (\\>10%) to develop islet autoantibodies by age 6 years as determined by a HLA DR\u002FDQ genotype, polygenic risk score and first-degree family history of type 1 diabetes status.\n3. Written informed consent signed by the custodial parent(s).\n\nExclusion Criteria:\n\n1. Previous hypersensitivity to the excipients of the vaccine.\n2. Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study. These include immune deficiencies, and conditions or treatments that lead to immune suppression.\n3. Likely poor compliance due to expected change in residency.\n4. Diagnosis of diabetes prior to recruitment or randomisation\n5. Current use of any other investigational drug",true,"ALL","3 Months","4 Months",{"count":202,"type":203},2252,"ESTIMATED","INTERVENTIONAL",[206],"PHASE4","The study GPPAD-05 AVAnT1A is a phase 4 clinical trial intending to enroll 2252 children, who will be randomly assigned to receive COVID-19 vaccination (Comirnaty® 3 μg Omicron XBB.1.5 or new variant Comirnaty vaccines ) or placebo from age 6 months.\n\nThe study is an investigator initiated, randomized, controlled, multicentre, multinational, primary prevention trial for children at increased risk of type 1 diabetes.\n\nThe primary objective is to determine whether vaccination of children with elevated genetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood.\n\nSecondary objectives are:\n\n1. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood.\n2. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and\n3. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of celiac disease-associated transglutaminase autoantibodies in childhood.\n\nFurther exploratory objectives are described in the study protocol.\n\nStudy participants will be identified through an ongoing study screening for genetic risk of type 1 diabetes using a polygenic risk score (NCT03316261).\n\nEligible participants will be enrolled at age 3.00 to 4.00 months (baseline visit).\n\nRandomization to vaccine or placebo will occur at age 6.00 to 7.00 months at visit 2. Consent will be obtained by the custodial parents prior to enrollment.",[209],"Diabetes Mellitus, Type 1",[211,212,213,214,215,216,217,218,219,220,221,222,223,224],"Type 1 diabetes","T1D","Diabetes mellitus","Autoantigen","Prevention","at risk for developing type 1 diabetes","Juvenile diabetes","Autoimmune diabetes","Corona","COVID-19","Viral infection","Viral infection surveillance","Immune response","Metabolism","2025-09-22",{"date":227,"type":228},"2025-09-23","ACTUAL",{"date":230,"type":228},"2024-05-08",{"date":232,"type":203},"2027-10",{"name":5,"class":6},9]