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New treatment option for Diabetes Mellitus, Type 1
Official title INfluenza VaccInation To Mitigate typE 1 Diabetes
ClinicalTrials.gov ID: NCT05585983
What this study is testing
What is Vaxigrip Tetra Sanofi Pasteur Europe?
Vaxigrip Tetra Sanofi Pasteur Europe is an investigational medicine, being studied as a potential treatment for diabetes mellitus, type 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 17
You may be able to join if
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- Written informed consent (parents, legal guardian).
You likely can't join 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)...
- 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.
- Written informed consent (parents, legal guardian).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Herning, Denmark
- Holbæk, Denmark
- Nykøbing Falster, Denmark
- Randers, Denmark
- Roskilde, Denmark
- Slagelse, Denmark
- Viborg, Denmark
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, 7 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Herning, Denmark; Holbæk, Denmark; Nykøbing Falster, Denmark and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.