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 11/07/2025

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 V5.0 AMENDMENT 4_31MAR2025.pdf

First published: 10/07/2025

English (1.14 MB - PDF)View document

C3671027_RSV VACCINE PROTOCOL V4.0 AMENDMENT 3_28OCT2024.pdf

First published: 10/07/2025

English (1.11 MB - PDF)View document

C3671027_RSV VACCINE PROTOCOL V3.0 AMENDMENT 2_14JUN2024.pdf

First published: 08/07/2025

English (1.12 MB - PDF)View document

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

Secondary tabs