Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2022-12-14
2027-05-01
Brief Summary
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Detailed Description
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In this trial we test the hypothesis that influenza vaccination is superior to no influenza vaccination in sustaining β cell function in early T1D. Secondary outcome measures include change in autoantibodies directed against antigens present in the pancreatic islets, measures of severity of disease, change in inflammatory markers, and antibody titers against the four viruses included in the vaccine.
Despite improvements in care, T1D is a leading cause of debilitating complications and early death globally. Children with residual β cell function are at lower risk for severe hypoglycemia, have better diabetes regulation, and have lower insulin requirements compared to children without residual β cell function. Thus, a simple, cheap treatment to mitigate T1D is highly warranted.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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.
Study Groups
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Influenza vaccination
Influenza vaccine, 0.5 mL.
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.
Placebo
Placebo, 0.5 mL saline.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent (parents, legal guardian).
Exclusion Criteria
* 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.
7 Years
17 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Ole Frøbert, MD, PhD
Professor
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Steno Diabetes Center Copenhagen
Copenhagen, , Denmark
Gødstrup Hospital
Herning, , Denmark
Holbaek Sygehus
Holbæk, , Denmark
Nykoebing F Sygehus
Nykøbing Falster, , Denmark
Randers Regional Hospital
Randers, , Denmark
Sjællands Universitetssygehus
Roskilde, , Denmark
Slagelse Hospital
Slagelse, , Denmark
Viborg Regional Hospital
Viborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Mette Madsen, MD
Role: primary
Jesper Johannesen
Role: primary
Jesper S Hjelle, MD
Role: primary
Annie Ellermann
Role: primary
Tatjana Zaharov
Role: primary
Britta Kremke, MD
Role: primary
Annette Mouritsen
Role: primary
Birgitte Dolmer
Role: primary
Ditte Adolfsen, MD, PhD
Role: primary
References
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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.
Other Identifiers
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INVITED-2022
Identifier Type: -
Identifier Source: org_study_id
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