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Notification report


Full notification file


General information

Notification Number
B/SE/10/EU-2010-019936-11

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
26/04/2010

Title of the Project
A phase 1, single centre, dose-escalating, placebo-controlled study of a genetically modified B. pertussis strain given as a single intranasal dose to healthy adult male volunteers

Proposed period of release:
01/08/2010 to 30/06/2011

Name of the Institute(s) or Company(ies)
Swedish institute for Infectious Disease
Control, Stockholm, Sweden;
Inserm, ;
Karolinska University Hospital, ;


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

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

GMO characterization

GMO is a:
Bacterium

Identity of the GMO:
Genetically attenuated strain of Bordetella pertussis (BPZE1)

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-BordetellaeB. pertussisTohama I

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known