B/BE/00/V15
| Company/Institution | Merial |
| Parental organism | Canarypoxvirus (ALVAC clone) |
| Transgene(s) | haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93 |
| Treated organism | Horses |
| Title of the project | Development of a combined vaccine against equine influenza and tetanus. Experiment outside containment (clinical trial) for the study of the safety and efficacy of an intramuscular administration of recombinant canarypoxvirus expressing equine influenza v |
| Treatment indication | vaccination against equine influenza virus |
| Administration route(s) | Intramuscular |
| Total number of subjects foreseen | 50 |
| Foreseen duration of release | 12 months |
| Effective year(s) of release | not communicated |
| Current status | trial completed |
| Locations | Gentbrugge and Bornem |
| Number of sites | 2 |
| Monitoring | |
| Type of procedure | Classical procedure - Art. 9§1 of Royal Decree of 18 December 1998 |
| Notes | |
| Other |
Information for the public
- B/BE/00/V15 - Fiche d'information destinée au public (préparée par le notifiant)
- B/BE/00/V15 – Informatie fiche bestemd voor het publiek (voorbereid door de kennisgever)
Information related to the decision procedure
-
B/BE/00/V15 - Avis du Conseil Consultatif de Biosécurité a.i.
18 December 2000: The Biosafety Advisory Council a.i. issues an advice (positive with conditions) for this trial (the advice is written in French)
-
B/BE/00/V15 – Advice of the Regional Competent Minister
5 January: The Regional Competent Minister issues a positive advice with conditions
-
B/BE/03/B3 - Decision of the Federal Public Service (FINAL DECISION)
14 March: The Federal Public Service Health, Food chain safety and Environment gives a final decision (positive with conditions) for this trial.
