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Notification report


Full notification file


General information

Notification Number
B/DE/08/PEI706

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
07/08/2008

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; Spain; Finland; United Kingdom;

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

If yes, notification number(s):
B/BE/08/BVW1; B/ES/08/49; B/FI/08/1MA; B/GB/09/R43/01;

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
bPIV3RespirovirusBovine Parainfluenza Virus Type 3bPIV3/15626/84

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
27/02/2009 00:00:00
Remarks: