RecruitingPhase 4NCT05585983

INfluenza VaccInation To Mitigate typE 1 Diabetes

INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)

Sponsor

Aarhus University Hospital

Enrollment

100 participants

Start Date

Dec 14, 2022

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

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

Min Age: 7 YearsMax Age: 17 Years

Inclusion Criteria2

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

Exclusion Criteria9

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.

Interventions

BIOLOGICALVaxigrip Tetra Sanofi Pasteur Europe

We will use 0.5 mL standard dose quadrivalent influenza vaccine containing 15 μg of hemagglutinin per strain consistent with WHO recommendations according to season.