INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)

Trial ID: NCT05585983

Interventional - Phase 4 - Recruiting

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

• Vaxigrip Tetra Sanofi Pasteur Europe

Eligibility

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.

Sponsor

Aarhus University Hospital

Source: ClinicalTrials.gov

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