Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
70
Countries
1
Sites
1
Influenza
Key facts
- Sponsor
- LiteVax B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 12 Jan 2024 → 10 Oct 2024
- Decision date (initial)
- 2023-12-22
- 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
Influenza
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10022000 | Influenza | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
LiteVax B.V.
- Sponsor organisation
- LiteVax B.V.
- Address
- Akkersestraat 50
- City
- Ophemert
- Postcode
- 4061 BJ
- Country
- Netherlands
Scientific contact point
- Organisation
- LiteVax B.V.
- Contact name
- Luuk Hilgers
Public contact point
- Organisation
- LiteVax B.V.
- Contact name
- Luuk Hilgers
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 70 | 1 |
| 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 | 2024-01-12 | 2024-10-10 | 2024-01-22 | 2024-04-05 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-12 | Belgium | Acceptable 2023-12-22
|
2023-12-22 |