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INfluenza VaccInation To Mitigate typE 1 Diabetes

RecruitingPhase 4Ages 7 Years - 17 YearsAllAarhus University Hospital
NCT05585983 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Vaxigrip Tetra Sanofi Pasteur Europe
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Where

10 sites
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Steno Diabetes Center Copenhagen
Copenhagen, Denmark
Gødstrup Hospital
Herning, Denmark
Holbaek Sygehus
Holbæk, Denmark
Nykoebing F Sygehus
Nykøbing Falster, Denmark
Randers Regional Hospital
Randers, Denmark
Sjællands Universitetssygehus
Roskilde, Denmark

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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