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Notification report


Full notification file


General information

Notification Number
B/ES/18/27

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
18/01/2019

Title of the Project
A Randomized, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-Seronegative Toddlers 12 to 24 Months of Age

Proposed period of release:
01/04/2019 to 01/10/2021

Name of the Institute(s) or Company(ies)
Janssen Vaccines & Prevention B.V., Archimedesweg 4-6
2333CP Leiden, The Netherlands;


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

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:
The identity of the GMO is Ad26.RSV.preF and is a replication incompetent adenovirus vector containing the sequence for the RSV Fusion (F) protein stabilized in a prefusion conformation. The Ad26.RSV.preF vector is derived from the human Adenovirus group D type 26 (genus Mastadenoviridae.).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Ad26MastadenovirusAdenovirus Group D-Type 26-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known