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)

02/05/2024
26/01/2026
EU PAS number:
EUPAS1000000115
Study
Ongoing
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Documents
Study protocol
Initial protocol

C3671027_RSV VACCINE FINAL PROTOCOL V1.0_15MAR2024.pdf

English (1.79 MB - PDF) View document
Updated protocol

C3671027_PROTOCOL AMENDMENT 5 V6.0_05JAN2026.pdf

First published: 21/01/2026
English (2.26 MB - PDF) View document

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