NCT05585983 INfluenza VaccInation To Mitigate typE 1 Diabetes
| NCT ID | NCT05585983 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Aarhus University Hospital |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-12-14 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2022-12-14 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In a multicenter, prospective, randomized, controlled clinical trial to compare influenza vaccination and placebo in sustaining β cell function in early type 1 diabetes mellitus.
Eligibility Criteria
Inclusion Criteria: * Patients hospitalized with newly diagnosed type 1 diabetes mellitus. * Written informed consent (parents, legal guardian). Exclusion Criteria: * Influenza vaccination during the current influenza season. * Strong indication for influenza vaccination for non-diabetic disease. * Severe allergy to eggs or previous allergic reaction to influenza vaccine. * Suspicion of febrile illness or acute, ongoing infection. * Hypersensitivity to the active substances or ingredients of Vaxigrip Tetra or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol. * Patients with endogenic or iatrogenic immunosuppression that may result in reduced immunization response. * Inability to provide informed consent from a parent or legal guardian. * Age \<7 or ≥18 years. * Previous randomization in the INVITED trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05585983 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05585983 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05585983 currently recruiting?
Yes, NCT05585983 is actively recruiting participants. Contact the research team at olefro@clin.au.dk for enrollment information.
Where is the NCT05585983 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Herning, Denmark and 6 additional locations.
Who is sponsoring the NCT05585983 clinical trial?
NCT05585983 is sponsored by Aarhus University Hospital. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.