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Clinical trial Recruiting at 10 sites Phase 4 Interventional Ages 7 to 17

Using influenza vaccination to help manage type 1 diabetes

Official title: INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)

Run by Aarhus University Hospital · NCT05585983 · Data updated 2026-11-12

This study is testing if getting the flu vaccine can help people with early type 1 diabetes keep their insulin-producing cells working better.

Quick facts

PhasePhase 4
Study typeInterventional
Ages7 Years to 17 Years
SexAll
Enrollment100 (estimated)
SponsorAarhus University Hospital
Academic / other
Locations10 sites (Aalborg and 9 other locations)
StatusRecruiting
StartedDecember 14, 2022
Main results expectedMay 1, 2027
Study endsMay 1, 2028
Registry record updatedOctober 28, 2026
Trial IDNCT05585983 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children and young adults aged 7 to 17 who have recently been diagnosed with type 1 diabetes and are hospitalized.

Probably not a fit

Patients who have received an influenza vaccination during the current season or have severe allergies to vaccine components may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of influenza vaccination on preserving β cell function in patients with early type 1 diabetes mellitus. It is a multicenter, prospective, randomized, controlled trial comparing the outcomes of patients receiving the influenza vaccine against those receiving a placebo. The study aims to determine if vaccination can sustain β cell function and improve disease management by measuring various health markers and immune responses. The trial is designed to provide insights into a potential immunotherapy approach for delaying the progression of type 1 diabetes.

Why it matters

Potential benefit: If successful, this approach could lead to a simple and cost-effective method to preserve insulin-producing cells in patients with early type 1 diabetes.

How similar studies have gone: While the concept of using vaccination to modulate autoimmune responses is promising, this specific approach has not been widely tested, making it a novel investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
* Written informed consent (parents, legal guardian).

Exclusion Criteria:

* Influenza vaccination during the current influenza season.
* Strong indication for influenza vaccination for non-diabetic disease.
* Severe allergy to eggs or previous allergic reaction to influenza vaccine.
* 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.
* Patients with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
* Inability to provide informed consent from a parent or legal guardian.
* Age \<7 or ≥18 years.
* Previous randomization in the INVITED trial.

Where it's running

  • Aalborg University Hospital
    Aalborg, Denmark     Recruiting
  • Aarhus University Hospital
    Aarhus, Denmark     Recruiting
  • Steno Diabetes Center Copenhagen
    Copenhagen, Denmark     Recruiting
  • Gødstrup Hospital
    Herning, Denmark     Recruiting
  • Holbaek Sygehus
    Holbæk, Denmark     Recruiting
  • Nykoebing F Sygehus
    Nykøbing Falster, Denmark     Recruiting
Show 4 more locations
  • Randers Regional Hospital
    Randers, Denmark     Recruiting
  • Sjællands Universitetssygehus
    Roskilde, Denmark     Recruiting
  • Slagelse Hospital
    Slagelse, Denmark     Recruiting
  • Viborg Regional Hospital
    Viborg, Denmark     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.