Full notification file
Member State to which the notification was sent
Date of acknowledgement from the Member State Competent Authority
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?
Has the same GMO been notified elsewhere by the same notifier?
If yes, notification number(s):
GMO is a:
Identity of the GMO:
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
Simian Adenovirus Subgroup C
European Commission administrative information
Consent given by the Member State Competent Authority: