Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
80
Countries
1
Sites
1
Pneumococcal infection
Key facts
- Sponsor
- LiteVax B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2024-11-19
- 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
Pneumococcal infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10036897 | Prophylactic vaccination | 10042613 |
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 | Authorised, recruitment pending | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Belgium | Acceptable 2024-11-19
|
2024-11-19 |