Public information presented according to the provisions of Directive 2001/18/EC
EU record number
B/BE/08/BVW1
EudraCT number
2008-002651-24
Company / Sponsor
MedImmune LLC
Phase
I/II a
Treated organism
Humans
Indication category
Infectious disease
Disease
lower respiratory tract illness
Therapeutic approach
Immunotherapy
Genetic modification
Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F).
Method of transfer of nucleic acid of interest
Attenuated Bovine Parainfluenza Virus type 3 strain bPIV3/15626/84
Administered biological material
Recombinant Attenuated Bovine Parainfluenza Virus
Route of administration
Intranasal
Locations in Belgium
Flanders, Wallonia and Brussels as a consequence of clinical trials conducted with children potentially recruited at: - UZ Brussels - St-Vincentiusziekenhuis, Antwerp.
Nr of subjects
20 to 30 subjects in Belgium; 720 worldwide
Foreseen duration
3 years
Type of procedure
Contained use and Deliberate release
Current status
Authorized
Pharmaceutical study code
MI-CP178