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INfluenza VaccInation To Mitigate typE 1 Diabetes

RECRUITINGPhase 4Sponsored by Aarhus University Hospital
Actively Recruiting
PhasePhase 4
SponsorAarhus University Hospital
Started2022-12-14
Est. completion2026-05-01
Eligibility
Age7 Years – 17 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05585983

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

Age: 7 Years – 17 YearsHealthy volunteers accepted
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.

Conditions2

DiabetesDiabetes Mellitus, Type 1

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