Full notification fileGeneral informationNotification NumberB/GB/10/R40/01Member State to which the notification was sentUnited KingdomDate of acknowledgement from the Member State Competent Authority17/12/2010Title of the ProjectUnderstanding 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 controlProposed period of release:01/03/2011 to 01/03/2014Name of the Institute(s) or Company(ies)Emergent Product Development UK Ltd, ;
3. Is the same GMO release planned elsewhere in the Community?NoHas the same GMO been notified elsewhere by the same notifier?NoGMO characterizationGMO is a:BacteriumIdentity of the GMO:Enterobacteriaceae: Salmonella entericaInformation relating to the recipient or parental organisms from wich the GMO is derived
European Commission administrative informationConsent given by the Member State Competent Authority:Yes09/03/2011 00:00:00Remarks: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.
|S. Typhi Ty2||Enterobacteriaceae||Salmonella enterica||serovar Typhi||Ty2||Not known|