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Notification report


Full notification file


General information

Notification Number
B/DE/17/PEI2969

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
22/12/2016

Title of the Project
Double blinded, randomized, Priorix®- and placebo-controlled, trial to evaluate the optimal dose of MV-CHIK vaccine (against chikungunya virus) in regard to immunogenicity, safety and tolerability in healthy volunteers

Proposed period of release:
01/04/2017 to 31/12/2017

Name of the Institute(s) or Company(ies)
Themis Bioscience GmbH, Muthgasse 11/2
1190 Vienna
Austria;


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:
RNA Virus

Identity of the GMO:
The MV-CHIK vaccine is a recombinant live attenuated virus vaccine that is based on the backbone of the Schwarz strain measles virus (MV) vaccine (derived from the Edmonston isolate). The heterologous antigens are derived from the Chikungunya (CHIK) virus (CHIKV).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
attenuated measles virusMorbillivirus--Schwarz strain-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
11/04/2017 00:00:00
Remarks: