INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 17
Healthy Volunteers: f
View:
• Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
• Written informed consent (parents, legal guardian).
Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Steno Diabetes Center Copenhagen
RECRUITING
Copenhagen
Gødstrup Hospital
RECRUITING
Herning
Holbaek Sygehus
RECRUITING
Holbæk
Nykoebing F Sygehus
RECRUITING
Nykøbing Falster
Randers Regional Hospital
RECRUITING
Randers
Sjællands Universitetssygehus
RECRUITING
Roskilde
Slagelse Hospital
RECRUITING
Slagelse
Viborg Regional Hospital
RECRUITING
Viborg
Contact Information
Primary
Ole Frøbert, MD, PhD
olefro@clin.au.dk
0046730895413
Backup
Mads F. Kjølby, MD, PhD
mads@dandrite.au.dk
004560866653
Time Frame
Start Date: 2022-12-14
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 100
Treatments
Experimental: Influenza vaccination
Influenza vaccine, 0.5 mL.
Placebo_comparator: Placebo
Placebo, 0.5 mL saline.
Related Therapeutic Areas
Sponsors
Leads: Aarhus University Hospital