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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers in hospital with newly diagnosed type 1 diabetes. It compares a flu vaccine with a placebo to see if it helps keep insulin-making cells working.
- Age
- 7 to 17 years (under 18)
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed type 1 diabetes, in hospital.
- Earlier treatment
- Cannot have had a flu vaccine during the current flu season.
Main reasons for not taking part
- Flu vaccine already given this flu season
- Strong reason for flu vaccination because of another illness
- Severe egg allergy or earlier allergic reaction to a flu vaccine
- Fever or an ongoing acute infection
- Weakened immune system that may reduce the response to vaccination
Read by machine on 9 November 2026.
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.