Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
144
Countries
1
Sites
2
Yellow fever
Key facts
- Sponsor
- AstriVax
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 16 Jun 2024 → 26 Jan 2026
- Decision date (initial)
- 2024-06-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Yellow fever
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10037742 | Rabies | 100000004862 |
| 20.0 | PT | 10048240 | Yellow fever | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstriVax
- Sponsor organisation
- AstriVax
- Address
- Ambachtenlaan 1
- City
- Leuven
- Postcode
- 3001
- Country
- Belgium
Scientific contact point
- Organisation
- AstriVax
- Contact name
- Mathieu Peeters
Public contact point
- Organisation
- AstriVax
- Contact name
- Hanne Callewaert
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 144 | 2 |
| 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 |
|---|---|---|---|---|---|
| Belgium | 2024-06-16 | 2026-01-26 | 2024-06-16 | 2026-01-26 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-15 | Belgium | Acceptable 2024-06-13
|
2024-06-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-19 | Belgium | Acceptable 2024-07-16
|
2024-07-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-18 | Belgium | Acceptable | 2024-08-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-13 | Belgium | Acceptable 2024-11-07
|
2024-11-07 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-13 | Belgium | Acceptable 2025-04-23
|
2025-04-23 |