INVITED trial
- Conditions
- Type 1 diabetesMedDRA version: 20.0Level: LLTClassification code: 10012609Term: Diabetes mellitus juvenile onset Class: 10027433Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- CTIS2022-500906-17-01
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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