Clinical trial • Phase IV • Infectious Disease | Endocrinology | Immunology | Other
RAXTOZINAMERAN for Type 1 diabetes | Islet autoimmunity
Phase IV trial of RAXTOZINAMERAN for Type 1 diabetes | Islet autoimmunity.
Overview
- Trial Therapeutic Area
- Infectious Disease | Endocrinology | Immunology | Other
- Trial Disease
- Type 1 diabetes | Islet autoimmunity
- Trial Stage
- Phase IV
- Drug Modality
- mRNA | Vaccine | Other
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 08-12-2023
- First CTIS Authorization Date
- 11-04-2024
Trial design
Randomised, comparator arm: 0.9% sodium chloride solution for injection (saline) (placebo). test arm: comirnaty omicron xbb.1.5 3 micrograms/dose concentrate for dispersion for injection covid-19 mrna vaccine (nucleoside modified) — dose listed as 3 µg per dose; product metadata lists maxtotaldoseamount 9 µg and maxtreatmentperiod 14 (time unit code 2).-controlled Phase IV trial in Sweden, Poland, Belgium and others.
- Randomised
- Yes
- Comparator
- Comparator arm: 0.9% Sodium Chloride solution for injection (saline) (placebo). Test arm: Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) — dose listed as 3 µg per dose; product metadata lists maxTotalDoseAmount 9 µg and maxTreatmentPeriod 14 (time unit code 2).
- Target Sample Size
- 267
Eligibility
Recruits 267 paediatric patients.
- Vulnerable Population
- Participants are infants (ages 3.00 to 4.00 months) and are identified as a vulnerable population; written informed consent must be signed by the custodial parent(s). Assent is not applicable for this age group.
Inclusion criteria
- {"criterion_text":"- Ages between 3.00 and 4.00 months at the time of enrollment\n- A high genetic risk (>10%) to develop islet autoantibodies by age 6 years as determined by a HLA DR/DQ genotype, polygenic risk score and first-degree family history of type 1 diabetes status\n- Written informed consent signed by the custodial parent(s)"}
Exclusion criteria
- {"criterion_text":"- 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.\n- Likely poor compliance due to expected change in residency.\n- Diagnosis of diabetes prior to recruitment or randomisation\n- Current use of any other investigational drug\n- Previous hypersensitivity to the excipients of the vaccine"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary efficacy outcome is the elapsed time from random treatment assignment to the development of persistent confirmed islet autoantibod-ies or type 1 diabetes","definition_or_measurement_approach":"Elapsed time from random treatment assignment to occurrence of persistent confirmed islet autoantibodies or diagnosis of type 1 diabetes (time-to-event analysis)."}
Secondary endpoints
- {"endpoint_text":"- The elapsed time from random treatment assignment to the development of per-sistent confirmed multiple islet autoan-tibodies; the development of type 1 diabetes; the development of persistent con-firmed transglutaminase autoantibodies","definition_or_measurement_approach":"Elapsed time from random treatment assignment to (a) development of persistent confirmed multiple islet autoantibodies, (b) development of type 1 diabetes, and (c) development of persistent confirmed transglutaminase autoantibodies (time-to-event endpoints)."}
Recruitment
- Planned Sample Size
- 267
- Recruitment Window Months
- 66
- Consent Approach
- Written informed consent must be signed by the custodial parent(s). Subject information and informed consent form documents are provided (multiple ICF documents referenced for different countries/languages). No participant assent is applicable given infant age.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 2365
Sweden
- Earliest CTIS Part Ii Submission Date
- 12-03-2024
- Latest Decision Or Authorization Date
- 11-04-2024
- Processing Time Days
- 30
- Number Of Sites
- 1
- Number Of Participants
- 325
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Pediatrics
- Contact Person Name
- Markus Lundgren
- Contact Person Email
- markus.lundgren@med.lu.se
Poland
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 15-04-2024
- Processing Time Days
- 31
- Number Of Sites
- 2
- Number Of Participants
- 580
Sites
- Site Name
- Clinical Trials Umed Sp. z o.o.
- Department Name
- Department of Pediatrics, Diabetology, Endocrinology & Nephrology
- Contact Person Name
- Agnieszka Szadkowska
- Contact Person Email
- agnieszka.szadkowska@umed.lodz.pl
- Site Name
- Warszawski Uniwersytet Medyczny
- Department Name
- Pediatrics
- Contact Person Name
- Agnieszka Szypowska
- Contact Person Email
- agnieszka.szypowska@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-03-2024
- Latest Decision Or Authorization Date
- 03-07-2024
- Processing Time Days
- 113
- Number Of Sites
- 1
- Number Of Participants
- 200
Sites
- Site Name
- UZ Leuven
- Department Name
- Pediatrics
- Contact Person Name
- Kristina Casteels
- Contact Person Email
- kristina.casteels@uzleuven.be
Germany
- Earliest CTIS Part Ii Submission Date
- 06-03-2024
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 733
- Number Of Sites
- 3
- Number Of Participants
- 880
Sites
- Site Name
- Technische Universitat Dresden
- Department Name
- Klinik und Poliklinik für Kinder und Jugendmedizin
- Contact Person Name
- Reinhard Berner
- Contact Person Email
- reinhard.berner@uniklinikum-dresden.de
- Site Name
- Hannoversche Kinderheilanstalt
- Department Name
- Diabetes Center
- Contact Person Name
- Olga Kordonouri
- Contact Person Email
- kordonouri@hka.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Institute for Diabetes Research
- Contact Person Name
- Anette-Gabriele Ziegler
- Contact Person Email
- anette-g.ziegler@helmholtz-munich.de
Austria
- Earliest CTIS Part Ii Submission Date
- 02-07-2025
- Latest Decision Or Authorization Date
- 24-07-2025
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 180
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Dept. of Pediatric and Adolescent Medicine
- Contact Person Name
- Birgit Rami-Merhar
- Contact Person Email
- Birgit.Rami@meduniwien.ac.at
Italy
- Earliest CTIS Part Ii Submission Date
- 11-03-2025
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 349
- Number Of Sites
- 1
- Number Of Participants
- 200
Sites
- Site Name
- Istituto San Raffaele
- Department Name
- General Medicine, Diabetes & Endocrinology
- Contact Person Name
- Emanuele Bosi
- Contact Person Email
- bosi.emanuele@hsr.it
Sponsor
Primary sponsor
- Full Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
- Active Substance
- RAXTOZINAMERAN
- Modality
- mRNA | Vaccine
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Marketing authorisation present (EU/1/20/1528/024 referenced)
- Starting Dose
- 3 µg per dose
- Maximum Dose
- 9 µg (maxTotalDoseAmount)
- Investigational Product Name
- 0.9% Sodium Chloride solution for injection (saline)
- Modality
- Other
- Authorisation Status
- Not applicable / placebo
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