Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
2,632
Countries
6
Sites
9
Risk for Type 1 Diabetes
To determine whether vaccination of children with elevated genetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in child-hood.
Key facts
- Sponsor
- Klinikum rechts der Isar der TU Muenchen AöR
- Participant type
- Pediatric, Healthy volunteers
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Health Care [N] - Environment and Public Health [N06], Diseases [C] - Virus Diseases [C02], Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 30 May 2024 → ongoing
- Decision date (initial)
- 2025-07-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- The Leona M and Harry B Helmsley Charitable Trust
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To determine whether vaccination of children with elevated genetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in child-hood.
Secondary objectives 3
- To determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood.
- To determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood.
- To determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of celiac disease-associated transglutami-nase autoantibodies in childhood.
Conditions and MedDRA coding
Risk for Type 1 Diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10012602 | Diabetes mellitus (incl subtypes) | 10027433 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Ages between 3.00 and 4.00 months at the time of enrollment
- A high genetic risk (>10%) to develop islet autoantibodies by age 6 years as determined by a HLA DR/DQ genotype, polygenic risk score and first-degree family history of type 1 diabetes status
- Written informed consent signed by the custodial parent(s)
Exclusion criteria 5
- Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant’s safe participation in the study. These include immune deficiencies, and conditions or treatments that lead to immune suppression.
- Likely poor compliance due to expected change in residency.
- Diagnosis of diabetes prior to recruitment or randomisation
- Current use of any other investigational drug
- Previous hypersensitivity to the excipients of the vaccine
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary efficacy outcome is the elapsed time from random treatment assignment to the development of persistent confirmed islet autoantibod-ies or type 1 diabetes
Secondary endpoints 1
- The elapsed time from random treatment assignment to the development of per-sistent confirmed multiple islet autoan-tibodies; the development of type 1 diabetes; the development of persistent con-firmed transglutaminase autoantibodies
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10815517 · Product
- Active substance
- Raxtozinameran
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 3 µg microgram(s)
- Max total dose
- 9 µg microgram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/024
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10813483 · Product
- Active substance
- Raxtozinameran
- Substance synonyms
- 5'-capped mRNA encoding SARS-CoV-2, Omicron variant XBB.1.5, Spike protein, pre-fusion stabilised (K981P and V982P)
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 3 µg microgram(s)
- Max total dose
- 9 µg microgram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/024
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10816539 · Product
- Active substance
- Raxtozinameran
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 3 µg microgram(s)
- Max total dose
- 9 µg microgram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/024
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10816069 · Product
- Active substance
- Raxtozinameran
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 3 µg microgram(s)
- Max total dose
- 9 µg microgram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/024
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
0.9% Sodium Chloride solution for injection (saline)
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Klinikum rechts der Isar der TU Muenchen AöR
- Sponsor organisation
- Klinikum rechts der Isar der TU Muenchen AöR
- Address
- Heidemannstrasse 1, Schwabing-Freimann Schwabing-Freimann
- City
- Munich
- Postcode
- 80939
- Country
- Germany
Scientific contact point
- Organisation
- Klinikum rechts der Isar der TU Muenchen AöR
- Contact name
- Anette-G. Ziegler
Public contact point
- Organisation
- Klinikum rechts der Isar der TU Muenchen AöR
- Contact name
- Anette-G. Ziegler
Locations
6 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 180 | 1 |
| Belgium | Ongoing, recruiting | 200 | 1 |
| Germany | Ongoing, recruiting | 880 | 3 |
| Italy | Authorised, recruitment pending | 200 | 1 |
| Poland | Not authorised | 580 | 2 |
| Sweden | Ongoing, recruiting | 325 | 1 |
| Rest of world
United Kingdom
|
— | 267 | — |
Investigational sites
Medical University Of Vienna
Dept. of Pediatric and Adolescent Medicine, Waehringer Guertel 18-20, Alsergrund, Vienna
Klinikum rechts der Isar der TU Muenchen AöR
Institute for Diabetes Research, Heidemannstrasse 1, Schwabing-Freimann, Munich
Hannoversche Kinderheilanstalt
Diabetes Center, Janusz-Korczak-Allee 12, Bult, Hanover
Technische Universitat Dresden
Klinik und Poliklinik für Kinder und Jugendmedizin, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Istituto San Raffaele
General Medicine, Diabetes & Endocrinology, Via Olgettina 58, 20132, Milan
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2026-03-03 | 2026-03-03 | |||
| Belgium | 2024-07-12 | 2024-08-08 | |||
| Germany | 2024-05-30 | 2024-05-30 | |||
| Sweden | 2024-06-17 | 2024-06-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 31 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Avant1a_Protocol | 2 |
| Recruitment arrangements (for publication) | AVAnT1A_20231110_recruitmentprocedure | 2 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT_redacted | 1 |
| Subject information and informed consent form (for publication) | AVAnT1A_ICF V1_Dresden_05Dec2023-1 | 2 |
| Subject information and informed consent form (for publication) | AVANT1A_ICF V1_HAN_final_05Dec2023-1 | 2 |
| Subject information and informed consent form (for publication) | AVANT1A_ICF_V1_Muc_final_05Dec2023-1 | 2 |
| Subject information and informed consent form (for publication) | AVAnT1A_ICF_V2_Dresden_05Mar2024_polish | 2 |
| Subject information and informed consent form (for publication) | AVANT1A_ICF_V2_MUC_05Mar2024_eng | 1 |
| Subject information and informed consent form (for publication) | AVANT1A_ReConsent_HAN_18Oct2023 | 2 |
| Subject information and informed consent form (for publication) | AVANT1A_ReConsent_MUC_09Oct2023 | 2 |
| Subject information and informed consent form (for publication) | AVANTIA_ReConsent_Dresden_18Oct2023 | 2 |
| Subject information and informed consent form (for publication) | L1_GPPAD-Biobank-Consent_Wien | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF_AVANT1A_data processing_IT | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_AVAnT1A_IT | 1.5 |
| Subject information and informed consent form (for publication) | L1_ICF_AVANT1A_Wien | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF_GPPAD_Biobank_IT | 1 |
| Subject information and informed consent form (for publication) | L1_Re-Consent_AVANT1A_IT | 1 |
| Subject information and informed consent form (for publication) | L1_Re-Consent_AVANT1A_Wien | 1.1 |
| Subject information and informed consent form (for publication) | Letter to Physician | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Dutch | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_english | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_German | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_italian | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Sweden | 3 |
| Synopsis of the protocol (for publication) | AVAnT1A_Synopsis_German | 2 |
| Synopsis of the protocol (for publication) | AVAnT1A_SYNOPSIS_Swedish | 2 |
| Synopsis of the protocol (for publication) | AVAnT1A_SynopsisDutch | 2 |
| Synopsis of the protocol (for publication) | AVAnT1A_SynopsisEnglish | 2 |
| Synopsis of the protocol (for publication) | AVAnT1A_SynopsisFrench | 2 |
| Synopsis of the protocol (for publication) | AVAnT1A_SynopsisPolish | 2 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-08 | Germany | Acceptable 2024-04-09
|
2024-04-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-24 | Acceptable | 2024-07-03 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-20 | Germany | Acceptable | 2024-08-20 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-03-11 | Acceptable 2024-04-09
|
2025-06-04 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-05-02 | 2025-07-24 | ||
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-07-25 | 2025-10-10 | ||
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-25 | Germany | 2025-07-25 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-21 | Germany | 2025-10-21 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-11-18 | Acceptable 2024-04-09
|
2026-02-23 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-09 | Germany | Acceptable 2024-04-09
|
2026-03-09 |