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Notification report


Full notification file


General information

Notification Number
B/ES/16/07

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
17/08/2016

Title of the Project
A study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ RSV investigational vaccine based on viral proteins encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) in RSVseropositive infants

Proposed period of release:
01/09/2016 to 31/01/2018

Name of the Institute(s) or Company(ies)
GlaxoSmithKline Biologicals, Rue de l’Institut, 89
1330 Rixensart, Belgium;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Italy;

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):


GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Family: Adenoviridae
Genus: Mastadenovirus
Species: this is a recombinant adenoviral vector (replication deficient) derived from simian
adenovirus subgroup C serotype 155
The identity of the GMO is ChAd155-RSV, as unique name for this recombinant vector.
ChAd155-RSV is a genetically modified organism derived from recombinant replicationdefective
simian (chimpanzee-derived) group C adenovirus serotype 155 (ChAd155). This
adenovirus is a member of the genus Mastadenovirus, which lies within the Adenoviridae family.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
ChAd155)MastadenovirusSimian Adenovirus Subgroup CN/Aserotype 155N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
18/10/2016 00:00:00
Remarks: