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Notification report


Full notification file


General information

Notification Number
B/DE/20/PEI4075

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
17/04/2020

Title of the Project
A phase III, randomized, double-blind, placebo-controlled, multicentre, clinical trial to assess the efficacy and safety of VPM1002 in reducing hospital admissions and/or severe respiratory infectious disease in elderly in the SARS-CoV-2 pandemic by modulating the immune system.

Proposed period of release:
01/05/2020 to 30/07/2020

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:
Bacteria; Actinobacteria; Actinomycetales; Corynebacterineae; Mycobacteriaceae; Mycobacterium; M. bovis; Strain BCG subtype Prague (recombinant Bacille Calmette Guérin (rBCG)).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
BCGMycobacteriumM. Bovis-BCG subtype Prague.

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
30/04/2020 00:00:00
Remarks: