NCT05585983RecruitingPhase 4
INfluenza VaccInation To Mitigate typE 1 Diabetes
INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 15 Oct 2022
- Start date
- 14 Dec 2022
- Primary completion date
- 1 May 2027
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Type 1 diabetes
- NCT number
- NCT05585983
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 14 Dec 2022 to the primary completion date, 1 May 2027
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov 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.
- Patients with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
- Inability to provide informed consent from a parent or legal guardian.
Who the study is looking for
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- Written informed consent (parents, legal guardian).
Age in the registry: 7 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Gødstrup Hospital Coordinator of this site? Confirm its status | Herning | Denmark | Recruiting |
| Holbaek Sygehus Coordinator of this site? Confirm its status | Holbæk | Denmark | Recruiting |
| Nykoebing F Sygehus Coordinator of this site? Confirm its status | Nykøbing Falster | Denmark | Recruiting |
| Randers Regional Hospital Coordinator of this site? Confirm its status | Randers | Denmark | Recruiting |
| Sjællands Universitetssygehus Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
| Slagelse Hospital Coordinator of this site? Confirm its status | Slagelse | Denmark | Recruiting |
| Viborg Regional Hospital Coordinator of this site? Confirm its status | Viborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.