Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Clinical 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 Infants

Proposed period of release:
01/04/2009 to 31/03/2012

Name of the Institute(s) or Company(ies)
MedImmune, LLC, ;

3. Is the same GMO release planned elsewhere in the Community?
Belgium; Germany; Spain; Finland; France; Italy;

Has the same GMO been notified elsewhere by the same notifier?

GMO characterization

GMO is a:
RNA Virus

Identity 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 genus

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar

European Commission administrative information

Consent given by the Member State Competent Authority:
01/02/2009 00:00:00
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.