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Notification report

Full notification file


General information

Notification Number
B/GB/10/R40/01

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
17/12/2010

Title of the Project
Understanding typhoid disease after vaccination: A single centre, randomized, double-blind, placebo-controlled study to evaluate M01ZH09 in a healthy volunteer challenge model with the licensed Ty21a vaccine as a positive control

Proposed period of release:
01/03/2011 to 01/03/2014

Name of the Institute(s) or Company(ies)
Emergent Product Development UK 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
S. Typhi Ty2	Enterobacteriaceae	Salmonella enterica	serovar Typhi	Ty2	Not known

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
09/03/2011 00:00:00
Remarks:
The GMO will be evaluated as a candidate oral vaccine against typhoid fever in a clinical study in healthy volunteers. The study is expected to last 3 years from March 2011. Any unanticipated adverse effects on volunteers would have to be reported in 72 hours and a report is required within 3 months of the date of the administration of the last date.