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Full notification Final report - General information Notification Number B/ES/23/22 Member State to which the notification was sent Spain Date of acknowledgement from the Member State Competent Authority 10/10/2023 Title of the Project Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus (RSV) vaccine in infants and toddlers. Proposed period of release: 01/05/2024 to 30/11/2024 Name of the Institute(s) or Company(ies) Sanofi-Aventis Recherche et Développement, 1, Avenue Pierre Brossolette 91385 Chilly-Mazarin France
Is the same GMO been notified elsewhere by the same notifier? Yes:
Germany; Finland; Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: RNA Virus Identity of the GMO: Orthopneumovirus, Respiratory Syncytial Virus Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Genus: Orthopneumovirus Species: Respiratory Syncytial Virus (RSV) Subspecies: N/A Strain: A2 Pathovar: N/A European Commission administrative Information Consent given by the Member State Competent Authority: Yes
01/10/2024