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Notification report

Full notification file


General information

Notification Number
B/GB/02/37/02

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
19/12/2002

Title of the Project
An open-label study to determine the safety and immunogenicity of two dose levels (10E8 or 10E9 CFU) of a candidate oral immunotherapy (Hep B Candidate 1) against hepatitis B, given on two occasions, 56 days apart to healthy subjects

Proposed period of release:
01/04/2003 to 30/06/2004

Name of the Institute(s) or Company(ies)
Microscience Ltd., ;


3. Is the same GMO release planned elsewhere in the Community?
No

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

GMO characterization

GMO is a:
Bacterium

Identity of the GMO:
Enterobacteriaceae: Salmonella enterica

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
Attenuated S. typhi Ty2	Enterobacteriaceae	Salmonella enterica	serovar Typhi	Ty2	Not known

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known