Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
85
Countries
1
Sites
1
Vaccination against shigellosis (in healthy adults)
Key facts
- Sponsor
- Academisch Ziekenhuis Leiden
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 12 Sep 2024 → 18 Feb 2026
- Decision date (initial)
- 2024-07-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506394-35-02
- ClinicalTrials.gov
- NCT05961059
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Vaccination against shigellosis (in healthy adults)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Academisch Ziekenhuis Leiden
- Sponsor organisation
- Academisch Ziekenhuis Leiden
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Academisch Ziekenhuis Leiden
- Contact name
- Meta Roestenberg
Public contact point
- Organisation
- Academisch Ziekenhuis Leiden
- Contact name
- Meta Roestenberg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 50 | 1 |
| Rest of world
Zambia
|
— | 35 | — |
Investigational sites
Academisch Ziekenhuis Leiden
Parasitology and Infectious Diseases, 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 | 2024-09-12 | 2025-09-26 | 2024-09-12 | 2025-02-05 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-05 | Netherlands | Acceptable 2024-07-02
|
2024-07-02 |