Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
184
Countries
1
Sites
3
Human Papilloma virus
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 22 Oct 2024 → 22 May 2026
- Decision date (initial)
- 2024-10-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515785-14-00
- WHO UTN
- U1111-1309-7794
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Human Papilloma virus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10063001 | Human papilloma virus infection | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Vivian Avelino-Silva
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Vivian Avelino-Silva
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 144 | 3 |
| Rest of world
United States
|
— | 40 | — |
Investigational sites
SGS Belgium
SGS Clinical Pharmacology Unit, Drie Eikenstraat 655, 2650, Edegem
Advanced Technology Corporation
Advanced Technology Corporation, Avenue De L'hopital 1, Etage 2e Tour 2 Route 124, Liege
Anima
Anima, Wetenschapspark 11-13, 3590, Diepenbeek
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 |
|---|---|---|---|---|---|
| Belgium | 2024-10-22 | 2026-05-22 | 2024-10-23 | 2026-05-21 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-BE-0001
- Member state
- Belgium
- Publication date
- 2025-02-12
- Type
- 3
- Reason
- 2
- Immediate action required
- Yes
- Justification
- Following response of the sponsor to the Ad Hoc assessment RFI, agreement on the proposed action by the sponsor :
- Recall of the concerned batches
- Restart of the trial via a SM
- Replacement of participants and safety follow up of participants who already received a dose
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-28 | Belgium | Acceptable 2024-10-21
|
2024-10-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-18 | Belgium | Acceptable 2025-01-17
|
2025-01-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-27 | Belgium | Acceptable 2025-03-14
|
2025-03-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-22 | Belgium | Acceptable 2025-08-05
|
2025-08-11 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-02 | Belgium | Acceptable 2025-08-05
|
2025-09-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-27 | Belgium | Acceptable 2026-05-08
|
2026-05-08 |