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Notification report

Full notification file


General information

Notification Number
B/FR/15/GT02

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
31/12/2014

Title of the Project
A phase I/IB randomized, double-blind, placebo controlled dose finding study to evaluate the safety, tolerability, and immune response of single and multiple dose of the hepatitis B specific replication-defective adenovirus serotype 5 (Ad5) vector based vaccine, TG1050, and an initial evaluation of immunologic and antiviral activity in the treatment of patients with chronic hepatitis B infection

Proposed period of release:
01/09/2014 to 31/12/2017

Name of the Institute(s) or Company(ies)
Transgene S.A., ;


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

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Mastadenovirus
Species: human adenovirus serotype 5 (Ad5)

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
Human adenovirus type 5	Mastadenovirus	human adenovirus	subgenus C	human serotype 5

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known