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Notification report

Full notification file


General information

Notification Number
B/BE/08/BVW1

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
28/10/2008

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:


Has the same GMPt 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 Name	Genus	Species	Subspecies	Strain	Pathovar
Bpiv3	Respirovirus			bPIV3/15626/84

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known