B/BE/08/BVW1

Company/Institution	MedImmune LLC
Parental organism	Modified bovine Parainfluenza virus
Transgene(s)	Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F).
Treated organism	Humans
Title of the project	MI-CP178: 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
Treatment indication	Vaccination of children and infants against Parainfluenza virus and Respiratory syncitial virus infections
Administration route(s)	intra-nasal
Total number of subjects foreseen	20 to 30 subjects in Belgium; 720 worldwide
Foreseen duration of release	3 years
Effective year(s) of release
Current status	Authorised
Locations	Flanders, Wallonia and Brussels as a consequence of clinical trials conducted with children potentially recruited at: - UZ Brussels - St-Vincentiusziekenhuis, Antwerp.
Number of sites	2 in Belgium
Monitoring
Type of procedure	Notification for deliberate release of GMO's other than higher plants for any other purpose than for placing on the market - submitted under the Royal Decree of 21 February 2005 on Deliberate release of genetically modified organisms - part B
Notes
Other

Information for the public

B/BE/08/BVW1 - Advice Biosafety Advisory Council
12 February 2008: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
B/BE/08/BVW1 - Decision of the Federal Minister (FINAL DECISION)
24 March 2009: The Federal Minister gives a final decision (positive) for this trial.
B/BE/08/BVW1 - Answers of the Biosafety Advisory Council to MedImmune with regards to new information concerning notification B/BE/08/BVW1
18 June 2009 - The Biosafety Advisory Council proposes to suppress one of the conditions of the authorization.