INVITED trial
Key facts
- Where
- Aalborg, Aarhus N, Herlev, Herning, Holbæk, Nykobing F, Randers Nø, Roskilde, Slagelse és Viborg, DániaSee the 10 sites
- Phase
- 2. fázis
Where in Dánia
- Aalborg University HospitalAalborg, DániaTaking people
- Aarhus UniversityAarhus N, DániaTaking people
- Steno Diabetes Center CopenhagenHerlev, DániaTaking people
- Region MidtjyllandHerning, DániaTaking people
- Holbaek SygehusHolbæk, DániaTaking people
- Nykoebing F SygehusNykobing F, DániaTaking people
- Regionshospitalet RandersRanders Nø, DániaTaking people
- Region SjaellandRoskilde, DániaTaking people
- Slagelse HospitalSlagelse, DániaTaking people
- Region MidtjyllandViborg, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aarhus University Hospital
- Trial code
- EU 2022-500906-17-01
- Record updated
- 2026. szeptember 7.
- Original description
To determine whether or not influenza vaccination will preserve β cell function in early type 1 diabetes mellitus.Read full original descriptionShow less
INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED trial)
To determine whether or not influenza vaccination will preserve β cell function in early type 1 diabetes mellitus.
Inclusion: Patients hospitalized with newly diagnosed type 1 diabetes mellitus; Male or female subjects ≥7 and <18 years; Written informed consent (parents, legal guardian).
Exclusion: Severe allergy to eggs or previous allergic reaction to influenza vaccine; Previous randomization in the INVITED trial; Strong indication for influenza vaccination for non-diabetic disease; 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; Age <7 or ≥18 years; Influenza vaccination during the current influenza season (September 1 – March 1); Patients with endogenic or iatrogenic immunosuppression that may result in reduced immunization response; Inability to provide informed consent.