A Rapid Surveillance and Cohort Post-Marketing Safety Study to Evaluate the Safety of Respiratory Syncytial Virus Vaccine (ABRYSVO™) Exposure During Pregnancy in the United States (C3671027)

First published 02/05/2024

Last updated 13/06/2025

EU PAS number:

EUPAS1000000115

Study

Ongoing

Documents

Study protocol

Initial protocol

C3671027_RSV VACCINE FINAL PROTOCOL V1.0_15MAR2024.pdf

English (1.79 MB - PDF)View document

Updated protocol

C3671027_RSV VACCINE PROTOCOL V2.0 AMENDMENT 1_21MAY2024.pdf

First published: 13/06/2025

English (2.19 MB - PDF)View document

Study results

Study report

Other information

ENCePP Seal

ENCePP Seal documents

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