INfluenza VaccInation To Mitigate typE 1 Diabetes

NCT05585983 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-22

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585983 on ClinicalTrials.gov