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INVITED trial
EU CTIS ID: 2022-500906-17-01
What this study is testing
To determine whether or not influenza vaccination will preserve β cell function in early type 1 diabetes mellitus.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- Male or female subjects ≥7 and <18 years.
- Written informed consent (parents, legal guardian).
You likely can't join if
- Influenza vaccination during the current influenza season (September 1 – March 1).
- 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.
See the full eligibility criteria
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- Male or female subjects ≥7 and <18 years.
- Written informed consent (parents, legal guardian).
- Influenza vaccination during the current influenza season (September 1 – March 1).
- 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.
- Age <7 or ≥18 years.
- Previous randomization in the INVITED trial.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.