Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
50
Countries
1
Sites
1
Booster immunisation against COVID-19 disease caused by SARS-CoV-2 virus
Key facts
- Sponsor
- Rokote Laboratories Finland Oy
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 27 Jan 2025 → 6 Aug 2025
- Decision date (initial)
- 2024-11-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509725-49-00
- WHO UTN
- U1111-1299-1228
- ClinicalTrials.gov
- NCT06851611
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Booster immunisation against COVID-19 disease caused by SARS-CoV-2 virus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10087820 | Vaccination booster dose | 100000004848 |
| 28.0 | LLT | 10087820 | Vaccination booster dose | 100000004848 |
| 28.0 | LLT | 10084462 | SARS-CoV-2 vaccination | 100000004865 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rokote Laboratories Finland Oy
- Sponsor organisation
- Rokote Laboratories Finland Oy
- Address
- Microkatu 1
- City
- Kuopio
- Postcode
- 70210
- Country
- Finland
Scientific contact point
- Organisation
- Rokote Laboratories Finland Oy
- Contact name
- CEO
Public contact point
- Organisation
- Rokote Laboratories Finland Oy
- Contact name
- CEO
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 50 | 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 |
|---|---|---|---|---|---|
| Finland | 2025-01-27 | 2025-08-06 | 2025-01-28 | 2025-06-26 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-18 | Finland | Acceptable with conditions 2024-11-04
|
2024-11-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-15 | Finland | Acceptable 2024-12-10
|
2024-12-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-27 | Finland | Acceptable 2024-12-10
|
2025-01-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-13 | Finland | Acceptable 2025-03-12
|
2025-03-12 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-03-14 | Finland | Acceptable 2025-03-12
|
2025-03-14 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-06-11 | Finland | Acceptable 2025-03-12
|
2025-06-11 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-25 | Finland | Acceptable 2025-08-05
|
2025-08-06 |