INVITED trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aarhus University Hospital

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Trial duration

21 Mar 2023 → ongoing

Decision date (initial)

2022-09-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

theflulab.org

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis

To determine whether or not influenza vaccination will preserve β cell function in early type 1 diabetes mellitus.

Conditions and MedDRA coding

Type 1 diabetes

Regulatory references

Plan to share IPD

Yes

IPD plan description

Data Collection: Data will be collected from patient records and electronic case report forms, including patient demographics, clinical outcomes, and laboratory results. Data Type: The dataset will include anonymized patient data, ensuring confidentiality in line with GDPR guidelines. Data Storage: Data will be stored in a secure, institutional repository with controlled access to maintain participant privacy and data integrity. Data Accessibility: Data will be available for other researchers upon reasonable request 12 months following publication of the primary outcomes data. Data Formats: Data will be available in R and Excel formats, facilitating use and analysis by others. Supporting Documentation: Metadata, study files, and analysis scripts will be included to ensure replicability of the study findings. Data Retention Period: Data will be available for a min. of 10 years post-publication. Contact Information: The corresponding author will be available for queries regarding thedata

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
2. Male or female subjects ≥7 and <18 years.
3. Written informed consent (parents, legal guardian).

Exclusion criteria 9

1. Influenza vaccination during the current influenza season (September 1 – March 1).
2. Strong indication for influenza vaccination for non-diabetic disease.
3. Severe allergy to eggs or previous allergic reaction to influenza vaccine.
4. Suspicion of febrile illness or acute, ongoing infection.
5. 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.
6. Patients with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
7. Inability to provide informed consent.
8. Age <7 or ≥18 years.
9. Previous randomization in the INVITED trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in fasting residual β cell (C-peptide) function, baseline to 12 months.

Secondary endpoints 5

1. Change in fasting C-peptide levels, baseline to 6 months.
2. Change in HbA1c, baseline to 12 months.
3. Change in insulin requirements, baseline to 12 months (measured as total insulin dose per kg body weight per day as a mean for the last 14 days).
4. Time-In-Range (3.9-10.0 mmol/L) of continuous glucose monitoring over 14 days at 12 months.
5. Percent coefficient of variation of glucose (%CV) over 14 days at 12 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aarhus University Hospital

Sponsor organisation

Aarhus University Hospital

Address

Palle Juul-Jensens Boulevard 82

City

Aarhus N

Postcode

8200

Country

Denmark

Scientific contact point

Organisation

Aarhus University Hospital

Contact name

Ole Frobert

Public contact point

Organisation

Aarhus University Hospital

Contact name

Mads Fuglsang Kjolby

Third parties 1

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications