Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruiting
Participants planned
20
Countries
1
Sites
1
Falciparum malaria
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Parasitic Diseases [C03]
- Trial duration
- 11 Mar 2026 → ongoing
- Decision date (initial)
- 2026-03-09
- 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
Falciparum malaria
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10083597 | Malaria immunisation | 100000004865 |
| 21.1 | LLT | 10016171 | Falciparum malaria | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leids Universitair Medisch Centrum (LUMC)
- Sponsor organisation
- Leids Universitair Medisch Centrum (LUMC)
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Meta Roestenberg
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Meta Roestenberg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Lumc
LUCID, Albinusdreef 2, 2333 ZA, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2026-03-11 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-07 | Netherlands | Acceptable 2026-03-09
|
2026-03-09 |