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Notification report


Full notification file


General information

Notification Number
B/BE/18/BVW2

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
24/04/2018

Title of the Project
A Phase 2, double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of two novel live attenuated serotype 2 oral poliovirus vaccines candidates, in healthy adults and adolescents previously vaccinated with oral polio vaccine (OPV) or inactivated polio vaccine (IPV), compared with historical controls given Sabin OPV2 or placebo.

Proposed period of release:
01/10/2018 to 30/06/2019

Name of the Institute(s) or Company(ies)
University of Antwerp, Centre for the Evaluation of Vaccination;


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:
Genus Enterovirus
Species Enterovirus C


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Sabin OPV2EnterovirusEnterovirus CPoliovirusSabin Type 2-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known