Overview
Sponsor-declared trial summary
This FTiH-PoC study aims to provide an early evaluation of the efficacy of the investigational vaccine as there are no established immunogenicity correlates of protection against infections caused by Neisseria gonorrhoeae.
Key facts
- Sponsor
- Glaxosmithkline Biologicals
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 2 Oct 2023 → 22 May 2025
- Decision date (initial)
- 2023-05-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500883-37-00
- ClinicalTrials.gov
- NCT05630859
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
This FTiH-PoC study aims to provide an early evaluation of the efficacy of the investigational vaccine as there are no established immunogenicity correlates of protection against infections caused by Neisseria gonorrhoeae.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Biologicals
- Sponsor organisation
- Glaxosmithkline Biologicals
- Address
- Rue De L'institut 89
- City
- Rixensart
- Postcode
- 1330
- Country
- Belgium
Scientific contact point
- Organisation
- Glaxosmithkline Biologicals
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Biologicals
- Contact name
- EU GSK Clinical Trials Call Center
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 187 | 3 |
| Germany | Ended | 305 | 3 |
| Spain | Ended | 100 | 5 |
| Rest of world
United States, South Africa, Brazil, Philippines, United Kingdom
|
— | 280 | — |
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 | 2023-10-03 | 2025-05-19 | 2023-10-03 | 2024-01-26 | |
| Germany | 2023-10-02 | 2025-05-21 | 2023-10-02 | 2024-01-19 | |
| Spain | 2023-10-02 | 2025-05-14 | 2023-10-02 | 2024-02-05 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2025-04-23
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- The sponsor is requested to submit a specific SM part II only in FRANCE in order to update its CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this CM.
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-09 | Germany | Acceptable 2023-05-02
|
2023-05-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-05-29 | Germany | Acceptable 2023-07-31
|
2023-08-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-31 | Germany | Acceptable 2023-07-31
|
2023-08-31 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-20 | Germany | Acceptable 2024-03-11
|
2024-03-11 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-04 | Germany | Acceptable 2024-08-19
|
2024-08-20 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-20 | Germany | Acceptable 2025-03-10
|
2025-03-11 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-30 | Acceptable 2025-03-10
|
2025-04-30 |