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B-GT/22: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
August 18, 2008
)
Title |
A multicenter phase 1 study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX 102-3697 HBV pDNA.INX 102-0557 HBV MVA in healthy volunteers and HBeAG+ chronic hepatitis patients |
Company or sponsor |
GENimmune N.V. |
Pharmaceutical study code |
|
| EudraCT number | |
Phase |
phase I |
Unicenter/multicenter study |
multicenter |
| Clinical data | see table 2 |
Installation |
|
Authorisation procedure 1 |
|
Application number |
|
User(s) |
|
Receipt date |
|
| Authorisation procedure 2 | deliberate release for research and development purposes (see regulation in French - in Dutch) |
| Application number | B/BE/07/BVW3 |
| 07/03/2008 | |
Authorisation date |
29/04/2008 |
Status |
study temporarily withdrawn by the notifier |
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