INfluenza VaccInation To Mitigate typE 1 Diabetes

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT05585983

Run by

Aarhus University Hospital

People needed

100

Starts

2022-12-14

Expected to finish

2027-05-01

Last updated by the study team

2025-05-22

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
• Written informed consent (parents, legal guardian).

You may not qualify if…

• 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.

Where it is running

• Aalborg University Hospital — Aalborg, Denmark (enrolling)
• Aarhus University Hospital — Aarhus, Denmark (enrolling)
• Steno Diabetes Center Copenhagen — Copenhagen, Denmark (enrolling)
• Gødstrup Hospital — Herning, Denmark (enrolling)
• Holbaek Sygehus — Holbæk, Denmark (enrolling)
• Nykoebing F Sygehus — Nykøbing Falster, Denmark (enrolling)
• Randers Regional Hospital — Randers, Denmark (enrolling)
• Sjællands Universitetssygehus — Roskilde, Denmark (enrolling)
• Slagelse Hospital — Slagelse, Denmark (enrolling)
• Viborg Regional Hospital — Viborg, Denmark (enrolling)

Full record on ClinicalTrials.gov

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