Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
128
Countries
1
Sites
3
Tuberculosis
Key facts
- Sponsor
- BioNTech SE
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 14 Apr 2023 → 8 Dec 2025
- Decision date (initial)
- 2024-03-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509515-89-00
- EudraCT number
- 2022-000911-29
- ClinicalTrials.gov
- NCT05537038
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Tuberculosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10072084 | Tuberculosis immunisation | 100000004865 |
| 21.1 | LLT | 10045023 | Tuberculosis prophylaxis | 10042613 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BioNTech SE
- Sponsor organisation
- BioNTech SE
- Address
- An Der Goldgrube 12, Oberstadt Oberstadt
- City
- Mainz
- Postcode
- 55131
- Country
- Germany
Scientific contact point
- Organisation
- BioNTech SE
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- BioNTech SE
- Contact name
- Clinical Trial Information Desk
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 128 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Germany | 2023-04-14 | 2025-12-08 | 2023-04-18 | 2024-06-19 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-01 | Germany | Acceptable 2024-03-12
|
2024-03-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | Germany | Acceptable 2024-07-30
|
2024-07-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-30 | Germany | Acceptable 2024-12-05
|
2024-12-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-17 | Germany | Acceptable 2025-07-15
|
2025-07-17 |