A Post-Authorisation Safety Study (PASS) of ABRYSVO (Respiratory Syncytial Virus Stabilised Prefusion Subunit Vaccine) in Pregnant Women and their Offspring in a Real World Setting in Europe and UK (C3671026)

13/01/2025
03/02/2026
EU PAS number:
EUPAS1000000399
Study
Ongoing
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Study identification

EU PAS number

EUPAS1000000399

Study ID

1000000399

Official title and acronym

A Post-Authorisation Safety Study (PASS) of ABRYSVO (Respiratory Syncytial Virus Stabilised Prefusion Subunit Vaccine) in Pregnant Women and their Offspring in a Real World Setting in Europe and UK (C3671026)

DARWIN EU® study

No

Study countries

Denmark
France
Netherlands
Norway
Spain
United Kingdom

Study description

This study is a retrospective comparative cohort study of pregnant women who receive ABRYSVO between 24-36 weeks of gestation compared to pregnant women who do not receive ABRYSVO at any time during their pregnancy. In addition, analyses will be stratified by immunocompromised status and high-risk pregnancies.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Teamit Institute
Spain
First published:
12/03/2024
Institution Other ENCePP partner

Networks

Contact details

Cynthia De Luise

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)