2022-500906-17-01RecruitingPhase 2
INVITED trial
INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED trial)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 Sept 2026
Brief summary (registry, in English)
To determine whether or not influenza vaccination will preserve β cell function in early type 1 diabetes mellitus.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 24 Jun 2022
- Start date
- 21 Mar 2023
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Type 1 diabetes
- EU CT number
- 2022-500906-17-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe allergy to eggs or previous allergic reaction to influenza vaccine.
- Previous randomization in the INVITED trial.
Other illness
- 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
- Age <7 or ≥18 years.
Other
- 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.
Who the study is looking for
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- Male or female subjects ≥7 and <18 years.
- Written informed consent (parents, legal guardian).
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | Recruiting |
| Aarhus University | Aarhus N | Denmark | Recruiting |
| Steno Diabetes Center Copenhagen | Herlev | Denmark | Recruiting |
| Region Midtjylland | Herning | Denmark | Recruiting |
| Holbaek Sygehus | Holbæk | Denmark | Recruiting |
| Nykoebing F Sygehus | Nykobing F | Denmark | Recruiting |
| Regionshospitalet Randers | Randers Nø | Denmark | Recruiting |
| Region Sjaelland | Roskilde | Denmark | Recruiting |
| Slagelse Hospital | Slagelse | Denmark | Recruiting |
| Region Midtjylland | Viborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.