Full notification fileGeneral informationNotification NumberB/GB/08/R43/01Member State to which the notification was sentUnited KingdomDate of acknowledgement from the Member State Competent Authority17/10/2008Title of the ProjectClinical Study MI-CP178, A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, 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 InfantsProposed period of release:01/04/2009 to 31/03/2012Name of the Institute(s) or Company(ies)MedImmune, LLC, ;
3. Is the same GMO release planned elsewhere in the Community?Yes: Belgium; Germany; Spain; Finland; France; Italy; Has the same GMO been notified elsewhere by the same notifier?NoGMO characterizationGMO is a:RNA VirusIdentity of the GMO:Bovine Parainfluenza virus type 3 (bPIV3) plasmid ‘backbone’: Respirovirus genus
Human Parainfluenza virus type 3 (hPIV3) F and HN genes: Respirovirus genus
Respiratory Syncytial virus (RSV) F gene: Pneumovirus genusInformation relating to the recipient or parental organisms from wich the GMO is derived
European Commission administrative informationConsent given by the Member State Competent Authority:Yes01/02/2009 00:00:00Remarks:The trial of the MEDI-534 vaccine will begin in April 2009 and be completed by March 2012. In England it will take place in 9 hospitals. A separate application has been submitted for a trial in Scotland.