Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000399

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

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

Planned
Research institutions and networks

Institutions

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

Networks

Contact details

Cynthia De Luise

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

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%
Study protocol
Initial protocol

C3671026_RSV VACCINE MATERNAL PROTOCOL_V2.0_06AUG2024.pdf

English (1.83 MB - PDF)View document
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)