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Notification report


Full notification file


General information

Notification Number
B/DE/08/PEI574

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
02/01/2008

Title of the Project
Phase I Open Label, Randomized, Controlled, Dose-Escalation Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison with BCG in Healthy Male Volunteers Stratified for History of BCG-Vaccination

Proposed period of release:
21/08/2008 to 23/11/2009

Name of the Institute(s) or Company(ies)
Vakzine Projekt Management GmbH, ;


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:
rBCGΔureC::Hly+::Hyg+ (VPM1002) (Mycobacterium bovis Bacille Calmette-Guérin (BCG) strain)

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
M. bovis Bacille Calmette-GuerinMycobacteriumbovisBCG subtype Prague

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
08/08/2008 00:00:00
Remarks: