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B-GT/23: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
June 21, 2011
)
Title |
Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants | |
Company or sponsor |
MedImmune | |
Pharmaceutical study code |
MI-CP178 | |
| EudraCT number | 2008-002651-24 | |
Phase |
phase I/II a | |
Unicenter/multicenter study |
multicenter | |
| Clinical data | see table 2 | |
Installation |
Sint Vincentius Ziekenhuis (Antwerpen) | UZ Brussel |
Authorisation procedure 1 |
contained use, subsequent use (see relevant regulation) | contained use, subsequent use (see relevant regulation) |
Application number |
219 2009/0217 |
219 2009/0263 |
User(s) |
Dr. Jonckheer | Prof. Dr. Anne Malfroot |
Receipt date |
12/03/2009 | 25/03/2009 |
| Authorisation date | 23/03/2009 | 17/04/2009 |
| Authorisation procedure 2 | deliberate release for research and development purposes (see regulation in French - in Dutch) | |
| Application number | B/BE/08/BVW1 | |
| 12/02/2009 | ||
Authorisation date |
24/03/2009 |
|
Status |
trial completed - no patients included in Belgium |
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