Actively Recruiting
INfluenza VaccInation To Mitigate typE 1 Diabetes
Led by Aarhus University Hospital · Updated on 2025-05-22
100
Participants Needed
10
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
INfluenza VaccInation To Mitigate typE 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- Written informed consent from parents or legal guardian.
- Age between 7 and 17 years.
You will not qualify if you...
- 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 Vaxigrip Tetra ingredients or residues such as eggs, neomycin, formaldehyde, or octoxinol.
- Endogenic or iatrogenic immunosuppression reducing immunization response.
- Inability to provide informed consent from a parent or legal guardian.
- Age under 7 years or 18 years and older.
- Previous randomization in the INVITED trial.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Aalborg University Hospital
Aalborg, Denmark
Actively Recruiting
2
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
3
Steno Diabetes Center Copenhagen
Copenhagen, Denmark
Actively Recruiting
4
Gødstrup Hospital
Herning, Denmark
Actively Recruiting
5
Holbaek Sygehus
Holbæk, Denmark
Actively Recruiting
6
Nykoebing F Sygehus
Nykøbing Falster, Denmark
Actively Recruiting
7
Randers Regional Hospital
Randers, Denmark
Actively Recruiting
8
Sjællands Universitetssygehus
Roskilde, Denmark
Actively Recruiting
9
Slagelse Hospital
Slagelse, Denmark
Actively Recruiting
10
Viborg Regional Hospital
Viborg, Denmark
Actively Recruiting
Research Team
O
Ole Frøbert, MD, PhD
CONTACT
M
Mads F. Kjølby, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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