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Notification report


Full notification file


General information

Notification Number
B/DE/16/PEI2797

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
21/06/2016

Title of the Project
Safety and immunogenicity study of a Clostridium difficile vaccine in healthy adult volunteers

Proposed period of release:
01/08/2016 to 30/10/2016

Name of the Institute(s) or Company(ies)
Royal Holloway and Bedford New College,
University of London, ;


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:
Bacteria/Firmicutes/Bacilli/Bacillales/Bacillaceae/Bacillus/Bacillus subtilis. The CDVAX drug substance has the following nomenclature: CDVAX drug substance. It can also be referred to as CDVAX spores, PP108 spores or B. Subtilis PP108 spores.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Bacillus subtilisBacillussubtilisMarburgPY79Bacilli

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
11/07/2016 00:00:00
Remarks: