Study identification

EU PAS number

EUPAS1000000629

Study ID

1000000629

Official title and acronym

Epidemiology of Guillain-Barré Syndrome and Risk Associated with Exposure to ABRYSVO Among Vaccinees 18-59 Years of Age in the United States

DARWIN EU® study

No

Study countries

United States

Study description

ABRYSVO is a bivalent, adjuvanted RSVpreF vaccine that has been approved for use in the United States (US) in adults 18-59 years of age at increased risk of respiratory syncytial virus-associated lower respiratory tract disease (RSV-LRTD), pregnant individuals at 32-36 weeks gestational age of pregnancy for the prevention of RSV-LRTD in infants, and in adults ≥60 years of age.
This is a post-authorization safety study (PASS) to monitor the incidence of Guillain-Barré Syndrome (GBS) in ABRYVSO-vaccinated adults 18-59 years of age at increased risk of RSV-LRTD.
This protocol additionally includes analyses of the epidemiology and natural history of GBS in the US. A better understanding of the epidemiology of GBS in the US, including preceding risk factors and contemporaneous background rates, is important to contextualize the risk of GBS after vaccinations and can inform vaccine safety studies of GBS risk.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Contact details

Jenny Sun

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)?

Non-EU RMP only