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Notification report

Full notification file


General information

Notification Number
B/FR/13/GT06

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
27/09/2013

Title of the Project
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT) (Study 0113-CL-1004)

Proposed period of release:
16/04/2013 to 30/04/2016

Name of the Institute(s) or Company(ies)
Astellas Pharma, Including, but not limited to, Astellas Pharma Global Development, Inc,
Astellas Pharma Europe B.V. And Astellas Pharma Inc.;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; Spain; Sweden;

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

GMO characterization

GMO is a:
Other: not applicable

Identity of the GMO:
The VCL-6365 and VCL-6368 pDNAs do not have a taxonomic classification.

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
N/A	N/A	N/A	N/A	N/A	N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known