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Notification report


Full notification file


General information

Notification Number
B/GB/08/R43/01

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
17/10/2008

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?
Yes:
Belgium; Germany; Spain; Finland; France; Italy;

Has the same GMO been notified elsewhere by the same notifier?
No

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
bPIV3RespirovirusbPIV3/15626/84

European Commission administrative information

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