Back

Notification report


Full notification file


General information

Notification Number
B/ES/18/33

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
16/11/2018

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 infants

Proposed period of release:
01/01/2019 to 31/12/2020

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:
Belgium; Finland; Italy; Poland;

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Order of the parental organism: Adenoviridae
Genus of the parental organism: Mastadenovirus
Species of the parental organism: Simian Adenovirus Subgroup C

The identity of the GMO is ChAd155-RSV, a 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
Chimpanzee adenovirus type 155MastadenovirusSimian Adenovirus Subgroup C-serotype 155-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known