Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
78
Countries
1
Sites
1
Immunocompromised individuals (phase 2a)
Key facts
- Sponsor
- Spikimm
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 10 Jul 2023 → ongoing
- Decision date (initial)
- 2023-07-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Immunocompromised individuals (phase 2a)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10084458 | COVID-19 prophylaxis | 100000004865 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Spikimm
- Sponsor organisation
- Spikimm
- Address
- 12 Rue Jean Antoine De Baif
- City
- Paris
- Postcode
- 75013
- Country
- France
Scientific contact point
- Organisation
- Spikimm
- Contact name
- Antoine Pau
Public contact point
- Organisation
- Spikimm
- Contact name
- Antoine Pau
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 78 | 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 |
|---|---|---|---|---|---|
| France | 2023-07-10 | 2023-07-10 | 2023-08-31 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-05 | France | Acceptable 2023-06-30
|
2023-07-03 |