Taking people in DenmarkPhase 2
Tests flu vaccine in young people with early type 1 diabetes
Tests whether flu vaccination protects insulin-making cells in early type 1 diabetes.
Key facts
- Who runs it
- Aarhus University Hospital
- Where
- Aalborg, Aarhus N, Herlev, Herning, Holbæk, Nykobing F, Randers Nø, Roskilde, Slagelse, and Viborg, DenmarkSee the 10 sites
- Trial code
- Registry title
- INVITED trial
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 100 people, planned
- Started
- 21 Mar 2023
- Expected to end
- 1 Jul 2027
- Type of study
- Interventional
- Record updated
- 7 September 2026
Who can take part
AI summary
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 tests whether a flu vaccine helps keep insulin-making cells working.
- Age
- From 7 years up to under 18 years.
- Sex
- Boys and girls can both join.
- Disease stage
- Newly diagnosed type 1 diabetes, in hospital.
- Earlier treatment
- No flu vaccination during the current flu season (September 1 – March 1).
Main reasons for not taking part
- Flu vaccination in the current flu season
- Strong reason for flu vaccination because of another disease
- Severe egg allergy or earlier allergic reaction to a flu vaccine
- Fever or an acute infection happening now
- Weakened immune system that may reduce the response to the vaccine
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus
- Male or female subjects ≥7 and <18 years
- Written informed consent (parents, legal guardian)
Who cannot take part
- 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
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Aarhus UniversityAarhus N, DenmarkTaking people
- Steno Diabetes Center CopenhagenHerlev, DenmarkTaking people
- Region MidtjyllandHerning, DenmarkTaking people
- Holbaek SygehusHolbæk, DenmarkTaking people
- Nykoebing F SygehusNykobing F, DenmarkTaking people
- Regionshospitalet RandersRanders Nø, DenmarkTaking people
- Region SjaellandRoskilde, DenmarkTaking people
- Slagelse HospitalSlagelse, DenmarkTaking people
- Region MidtjyllandViborg, DenmarkTaking people
About the trial
What the trial wants to find out
To determine whether or not influenza vaccination will preserve β cell function in early type 1 diabetes mellitus.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED trial)
- Plain-language title
- Tests flu vaccine in young people with early type 1 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 7 September 2026