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

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving an influenza (flu) vaccine to children newly diagnosed with type 1 diabetes helps preserve some of their remaining insulin-producing cells. The idea is that the flu vaccine may reduce immune activation that attacks the pancreas right after diagnosis. **You may be eligible if...** - You are a child (or parent/guardian) hospitalized with a new diagnosis of type 1 diabetes - Informed consent can be provided by a parent or legal guardian **You may NOT be eligible if...** - The child already received a flu vaccine this season - There is a strong medical reason to get the flu vaccine unrelated to diabetes - There is a severe egg allergy or previous allergic reaction to the flu vaccine - The child currently has a fever or active infection - The child has a condition causing immune suppression that may reduce vaccine effectiveness - A parent or guardian is unable to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.