Flu vaccine tested in children and teens with early type 1 diabetes
Tests a flu vaccine against placebo in children with early type 1 diabetes.
Plain-language title generated from the registry record
Registry title: INfluenza VaccInation To Mitigate typE 1 Diabetes
Key facts
- Where
- Aalborg, Aarhus, Copenhagen, Herning, Holbæk, Nykøbing Falster, Randers, Roskilde, Slagelse, and Viborg, DenmarkSee the 10 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 17 years old?
Source: NCT05585983, who can take part
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Aarhus University HospitalAarhus, DenmarkTaking people
- Steno Diabetes Center CopenhagenCopenhagen, DenmarkTaking people
- Gødstrup HospitalHerning, DenmarkTaking people
- Holbaek SygehusHolbæk, DenmarkTaking people
- Nykoebing F SygehusNykøbing Falster, DenmarkTaking people
- Randers Regional HospitalRanders, DenmarkTaking people
- Sjællands UniversitetssygehusRoskilde, DenmarkTaking people
- Slagelse HospitalSlagelse, DenmarkTaking people
- Viborg Regional HospitalViborg, DenmarkTaking 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
- NCT05585983
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)
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.
Inclusion: Patients hospitalized with newly diagnosed type 1 diabetes mellitus; 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; Patients with endogenic or iatrogenic immunosuppression that may result in reduced immunization response; Inability to provide informed consent from a parent or legal guardian.