INfluenza VaccInation To Mitigate typE 1 Diabetes

NCT05585983 | Recruiting Phase 4 DMC

• 1 other identifier: INVITED-2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in fasting residual β cell (C-peptide) function.

  Measured as the area under the concentration-time curve (AUC) for mixed-meal tolerance test-stimulated C-peptide concentration over 4 hours relative to baseline (AUC 0-4 h, C-peptide, 12 months/ AUC 0-4 h, C-peptide, baseline)

  12 months

Secondary Outcomes (5)

• Change in fasting residual β cell (C-peptide) function.

  6 months.

• Change in HbA1c

  12 months.

• Change in insulin requirements.

  12 months.

• Time-In-Range of blood glucose.

  12 months.

• Variation of blood glucose.

  12 months.

Other Outcomes (18)

• Proportion of participants with stimulated C-peptide >0.2 pmol/mL

  12 months

• HbA1c time in range

  12 months.

• Insulin Dose Adjusted A1c

  12 months

Study Arms (2)

Influenza vaccination

EXPERIMENTAL

Influenza vaccine, 0.5 mL.

Biological: Vaxigrip Tetra Sanofi Pasteur Europe

Placebo

PLACEBO COMPARATOR

Placebo, 0.5 mL saline.

Biological: Vaxigrip Tetra Sanofi Pasteur Europe

Interventions

Vaxigrip Tetra Sanofi Pasteur Europe BIOLOGICAL

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.

Influenza vaccination; Placebo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (10)

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

Randers Regional Hospital

Randers, Denmark

RECRUITING

Sjællands Universitetssygehus

Roskilde, Denmark

RECRUITING

Slagelse Hospital

Slagelse, Denmark

RECRUITING

Viborg Regional Hospital

Viborg, Denmark

RECRUITING

Related Publications (1)

• Pedersen IB, Kjolby M, Hjelholt AJ, Madsen M, Christensen AR, Adolfsen D, Hjelle JS, Kremke B, Stovring H, Jessen N, Vestergaard ET, Kristensen K, Frobert O. INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED): a study protocol for a randomised, double-blind, placebo-controlled clinical trial in children and adolescents with recent-onset type 1 diabetes. BMJ Open. 2024 Jul 1;14(6):e084808. doi: 10.1136/bmjopen-2024-084808.

  PMID: 38950997 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Ole Frøbert, MD, PhD

CONTACT

0046730895413; olefro@clin.au.dk

Mads F. Kjølby, MD, PhD

CONTACT

004560866653; mads@dandrite.au.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The following are masked in the study: Participant, Care Provider, Investigator, Outcomes Assessor. The following are not masked: unblinded study nurses at participating sites randomizing participants in the eCRF system. The unblinded study nurses are not otherwise involved or participating in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: In this double blind, placebo-controlled clinical trial participants are allocated to either influanza vaccination (active) or to placebo (control).

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 19, 2022
• Study Start: December 14, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

DK (10)