INfluenza VaccInation To Mitigate typE 1 Diabetes
NCT05585983 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-05-22
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.
Conditions
- Diabetes Mellitus, Type 1
Interventions
- BIOLOGICAL
-
Vaxigrip Tetra Sanofi Pasteur Europe
We will use 0.5 mL standard dose quadrivalent influenza vaccine containing 15 μg of hemagglutinin per strain consistent with WHO recommendations according to season.
Sponsors & Collaborators
-
Aarhus University Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-14
- Primary Completion
- 2026-05-01
- Completion
- 2027-05-01
Countries
- Denmark
Study Locations
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