Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
45
Countries
1
Sites
1
Prophylactic vaccination against HPV in healthy volunteers
Key facts
- Sponsor
- Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 7 Oct 2022 → ongoing
- Decision date (initial)
- 2024-06-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511493-67-00
- EudraCT number
- 2021-002584-22
- ClinicalTrials.gov
- NCT05208710
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Prophylactic vaccination against HPV in healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Sponsor organisation
- Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Address
- Im Neuenheimer Feld 280, Neuenheim Neuenheim
- City
- Heidelberg
- Postcode
- 69120
- Country
- Germany
Scientific contact point
- Organisation
- Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Contact name
- Scientific Trial Coordination
Public contact point
- Organisation
- Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Contact name
- Scientific Trial Coordination
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 45 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Heidelberg AöR
Department of Clinical Pharmacology and Pharmacoepidemiology, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
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 |
|---|---|---|---|---|---|
| Germany | 2022-10-07 | 2022-10-07 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-28 | Germany | Acceptable 2024-06-06
|
2024-06-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-28 | Germany | Acceptable 2024-06-06
|
2025-04-28 |