RECRUITINGPhase 4INTERVENTIONAL
INfluenza VaccInation To Mitigate typE 1 Diabetes
INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- Written willing to sign a consent form (parents, legal guardian).
Who Should NOT Join This Trial:
- 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 willing to sign a consent form from a parent or legal guardian.
- Age \<7 or ≥18 years.
- Previous randomization in the INVITED trial.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
* Written informed consent (parents, legal guardian).
Exclusion Criteria:
* 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.
Treatments Being Tested
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.
Locations (10)
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