| Trial ID: | L7388 |
| Source ID: | NCT06452654
|
| Associated Drug: |
Comirnaty Injectable Product
|
| Title: |
Anti-viral Action Against Type 1 Diabetes Autoimmunity
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Comirnaty Injectable Product|DRUG: Sodium Chloride 0.9% Inj
|
| Outcome Measures: |
Primary: Persistent confirmed islet autoantibodies or type 1 diabetes, The primary outcome is the elapsed time from first vaccination to the development of persistent confirmed islet autoantibodies or type 1 diabetes., Through study completion, up to 6 years | Secondary: Persistent confirmed multiple islet autoantibodies, Elapsed time from first vaccination to persistent confirmed multiple islet autoantibodies;, Through study completion, up to 6 years|Type 1 diabetes, Elapsed time from first vaccination to type 1 diabetes., Through study completion, up to 6 years|Persistent confirmed transglutaminase autoantibodies, Elapsed time from first vaccination to the development of persistent confirmed transglutaminase autoantibodies., Through study completion, up to 6 years
|
| Sponsor/Collaborators: |
Sponsor: Technical University of Munich | Collaborators: Helmholtz Zentrum München|University Hospital Carl Gustav Carus|Kinderkrankenhaus auf der Bult|Skane University Hospital|Universitaire Ziekenhuizen KU Leuven|Newcastle-upon-Tyne Hospitals NHS Trust|Cambridge University Hospitals NHS Foundation Trust|Birmingham Women's and Children's NHS Foundation Trust
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE4
|
| Enrollment: |
2252
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2024-05-08
|
| Completion Date: |
2027-10
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-10
|
| Locations: |
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven, Leuven, 3000, Belgium|Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Munich, Bavaria, 80939, Germany|AUF DER BULT, Kinder- und Jugendkrankenhaus, Hanover, Niedersachsen, 30173, Germany|Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden, Sachsen, 01307, Germany|Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS, Malmö, 20213, Sweden|Birmingham Women's and Children's NHS Foundation Trust, Birmingham, United Kingdom|Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom|The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT06452654
|
