Study identification

EU PAS number

EUPAS1000000115

Study ID

1000000115

Official title and acronym

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)

DARWIN EU® study

No

Study countries

United States

Study description

The study will estimate the risk of adverse pregnancy, maternal, and neonatal/infant outcomes among individuals who are exposed to ABRYSVO (RSVpreF) between 32 0/7 through 36 6/7 weeks gestation during pregnancy.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Contact details

Sarah MacDonald

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
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable