Diabetes Mellitus, Type 1Phase 4INVITEDNCT05585983
INfluenza VaccInation To Mitigate typE 1 Diabetes
A Phase 4 study testing Vaxigrip Tetra Sanofi Pasteur Europe in people with Diabetes Mellitus, Type 1, run by Aarhus University Hospital at 10 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Vaxigrip Tetra Sanofi Pasteur Europe
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 10 sitesDenmark
- Study dates
- 14 Dec 2022to 1 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- Written informed consent (parents, legal guardian).
Who cannot join
- 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.
Show all 9Show fewer
- Inability to provide informed consent from a parent or legal guardian.
- Age <7 or ≥18 years.
- Previous randomization in the INVITED trial.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Denmark10 sites, 10 recruiting
- Recruiting
Aalborg University Hospital
Aalborg
Mette Madsen, MD
- Recruiting
Aarhus University Hospital
Aarhus
Kurt Kristensen, MD, PhD, kurtkris@rm.dk
- Recruiting
Steno Diabetes Center Copenhagen
Copenhagen
Jesper Johannesen
- Recruiting
Gødstrup Hospital
Herning
Jesper S Hjelle, MD
- Recruiting
Holbaek Sygehus
Holbæk
Annie Ellermann
- Recruiting
Nykoebing F Sygehus
Nykøbing Falster
Tatjana Zaharov
- Recruiting
Randers Regional Hospital
Randers
Britta Kremke, MD
- Recruiting
Sjællands Universitetssygehus
Roskilde
Annette Mouritsen
- Recruiting
Slagelse Hospital
Slagelse
Birgitte Dolmer
- Recruiting
Viborg Regional Hospital
Viborg
Ditte Adolfsen, MD, PhD
About this study
Official title: INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED 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.
Read the detailed description
Type 1 diabetes (T1D) is an autoimmune disease in which T cells attack and destroy the insulin-producing β cells in the pancreatic islets. In theory, immunotherapies aimed at re-programming the immune system to avoid β cell destruction is a promising strategy to prevent T1D or delay onset of overt disease.
In this trial we test the hypothesis that influenza vaccination is superior to no influenza vaccination in sustaining β cell function in early T1D. Secondary outcome measures include change in autoantibodies directed against antigens present in the pancreatic islets, measures of severity of disease, change in inflammatory markers, and antibody titers against the four viruses included in the vaccine.
Despite improvements in care, T1D is a leading cause of debilitating complications and early death globally. Children with residual β cell function are at lower risk for severe hypoglycemia, have better diabetes regulation, and have lower insulin requirements compared to children without residual β cell function. Thus, a simple, cheap treatment to mitigate T1D is highly warranted.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Vaxigrip Tetra Sanofi Pasteur Europe
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaxigrip Tetra Sanofi Pasteur EuropeBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccination | Experimental | Influenza vaccine, 0.5 mL. Receives: Biological: Vaxigrip Tetra Sanofi Pasteur Europe |
| Placebo | Placebo comparator | Placebo, 0.5 mL saline. Receives: Biological: Vaxigrip Tetra Sanofi Pasteur Europe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting residual β cell (C-peptide) function.
Measured as the area under the concentration-time curve (AUC) for mixed-meal tolerance test-stimulated C-peptide concentration over 4 hours relative to baseline (AUC 0-4 h, C-peptide, 12 months/ AUC 0-4 h, C-peptide, baseline)
Measured: 12 months
Secondary outcomes (5)
Change in fasting residual β cell (C-peptide) function.
Measured as the area under the concentration-time curve (AUC) for mixed-meal tolerance test-stimulated C-peptide concentration over 4 hours relative to baseline (AUC 0-4 h, C-peptide, 6 months/ AUC 0-4 h, C-peptide, baseline)
Measured: 6 months.
Change in HbA1c
Measured as standard laboratory test in mmol/mol
Measured: 12 months.
Change in insulin requirements.
Measured as total insulin dose per kg body weight per day as a mean for the last 14 days.
Measured: 12 months.
Time-In-Range of blood glucose.
Defined as percentage time in range (3.9-10.0 mmol/L) of continuous glucose monitoring over 14 days.
Measured: 12 months.
Variation of blood glucose.
Determined as percent coefficient of variation of blood glucose over 14 days.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start14 Dec 2022
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this double blind, placebo-controlled clinical trial participants are allocated to either influanza vaccination (active) or to placebo (control).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Frøbert, MD, PhD, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585983
- Sponsor's protocol ID
- INVITED-2022
- Acronym
- INVITED
- Status last verified
- May 2025
- First submitted
- 15 Oct 2022
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pedersen IB, Kjolby M, Hjelholt AJ, Madsen M, Christensen AR, Adolfsen D, Hjelle JS, Kremke B, Stovring H, Jessen N, Vestergaard ET, Kristensen K, Frobert O. INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED): a study protocol for a randomised, double-blind, placebo-controlled clinical trial in children and adolescents with recent-onset type 1 diabetes. BMJ Open. 2024 Jul 1;14(6):e084808. doi: 10.1136/bmjopen-2024-084808.
PubMed 38950997
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)
- ClinicalTrials.gov ID
- NCT05585983
- Acronym / sponsor ID
- INVITED / INVITED-2022
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 1 diabetes (T1D) is an autoimmune disease in which T cells attack and destroy the insulin-producing β cells in the pancreatic islets. In theory, immunotherapies aimed at re-programming the immune system to avoid β cell destruction is a promising strategy to prevent T1D or delay onset of overt disease.
In this trial we test the hypothesis that influenza vaccination is superior to no influenza vaccination in sustaining β cell function in early T1D. Secondary outcome measures include change in autoantibodies directed against antigens present in the pancreatic islets, measures of severity of disease, change in inflammatory markers, and antibody titers against the four viruses included in the vaccine.
Despite improvements in care, T1D is a leading cause of debilitating complications and early death globally. Children with residual β cell function are at lower risk for severe hypoglycemia, have better diabetes regulation, and have lower insulin requirements compared to children without residual β cell function. Thus, a simple, cheap treatment to mitigate T1D is highly warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this double blind, placebo-controlled clinical trial participants are allocated to either influanza vaccination (active) or to placebo (control).
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccination | Experimental | Biological: Vaxigrip Tetra Sanofi Pasteur EuropeInfluenza vaccine, 0.5 mL. |
| Placebo | Placebo comparator | Biological: Vaxigrip Tetra Sanofi Pasteur EuropePlacebo, 0.5 mL saline. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients hospitalized with newly diagnosed type 1 diabetes mellitus.
- Written informed consent (parents, legal guardian).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaxigrip Tetra Sanofi Pasteur EuropeWe will use 0.5 mL standard dose quadrivalent influenza vaccine containing 15 μg of hemagglutinin per strain consistent with WHO recommendations according to season. | Biological | Influenza vaccination, Placebo |
Primary outcome
Change in fasting residual β cell (C-peptide) function.
Time frame: 12 months
Measured as the area under the concentration-time curve (AUC) for mixed-meal tolerance test-stimulated C-peptide concentration over 4 hours relative to baseline (AUC 0-4 h, C-peptide, 12 months/ AUC 0-4 h, C-peptide, baseline)
5 secondary outcomes
Change in fasting residual β cell (C-peptide) function.
Time frame: 6 months.
Change in HbA1c
Time frame: 12 months.
Change in insulin requirements.
Time frame: 12 months.
Time-In-Range of blood glucose.
Time frame: 12 months.
Variation of blood glucose.
Time frame: 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 38950997Pedersen IB, Kjolby M, Hjelholt AJ, Madsen M, Christensen AR, Adolfsen D, Hjelle JS, Kremke B, Stovring H, Jessen N, Vestergaard ET, Kristensen K, Frobert O. INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED): a study protocol for a randomised, double-blind, placebo-controlled clinical trial in children and adolescents with recent-onset type 1 diabetes. BMJ Open. 2024 Jul 1;14(6):e084808. doi: 10.1136/bmjopen-2024-084808.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaxigrip Tetra Sanofi Pasteur Europe in people with Diabetes Mellitus, Type 1, run by Aarhus University Hospital at 10 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ole Frøbert, MD, PhD (0046730895413, olefro@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting residual β cell (C-peptide) function. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05585983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.