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New treatment option for Diabetes Mellitus, Type 1
Official title Anti-viral Action Against Type 1 Diabetes Autoimmunity
ClinicalTrials.gov ID: NCT06452654
What this study is testing
What is Comirnaty Injectable Product?
Comirnaty Injectable Product is an investigational medicine, being studied as a potential treatment for diabetes mellitus, type 1.
Also referred to as Comirnaty 3µg/dose for children for 6 month - 4 years.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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. The study is an investigator initiated, randomized, controlled, multicentre, multinational, primary prevention trial for children at increased risk of type 1 diabetes.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 4. Healthy volunteers may be eligible.
You may be able to join if
- Ages between 3.00 and 4.00 months at the time of enrollment.
- 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...
- Written informed consent signed by the custodial parent(s).
You likely can't join if
- Previous hypersensitivity to the excipients of the vaccine.
- Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe...
- Likely poor compliance due to expected change in residency.
- Diagnosis of diabetes prior to recruitment or randomisation
- Current use of any other investigational drug
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Leuven, Belgium
- Munich, Bavaria, Germany
- Hanover, Lower Saxony, Germany
- Dresden, Saxony, Germany
- Malmö, Sweden
- Birmingham, United Kingdom
- Cambridge, United Kingdom
- Newcastle, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 4 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Leuven, Belgium; Munich, Bavaria, Germany; Hanover, Lower Saxony, Germany; Dresden, Saxony, Germany; Malmö, Sweden and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.