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
EU record number:
Pharmaceutical study code:
Company / Sponsor:
lower respiratory tract illness
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:
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
Type of procedure:
Contained use and Deliberate release
Information for the public
Public information presented according to the provisions of Directive 2001/18/EC
Information related to the decision procedure
18 June 2009 - The Biosafety Advisory Council proposes to suppress one of the conditions of the authorization.
12 February 2008: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
24 March 2009: The Federal Minister gives a final decision (positive) for this trial.