Study identification

EU PAS number

EUPAS1000000389

Study ID

1000000389

Official title and acronym

Effectiveness of ABRYSVO® maternal respiratory syncytial virus (RSV) vaccine against RSV in infants in Western Pennsylvania (CASSATT)

DARWIN EU® study

No

Study countries

United States

Study description

Globally, respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract disease (LRTD) in infants. Pfizer has developed ABRYSVO—a bivalent RSV prefusion F protein-based vaccine (RSVpreF) composed of two prefusion F proteins to protect against both RSV-A and RSV-B.
In the United States, ABRYSVO has been approved and recommended for active immunization of pregnant individuals from 32 0/7 to 36 6/7 weeks’ gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.

To generate critical evidence to support vaccine policy and implementation, Pfizer will collaborate with University of Pittsburgh to study vaccine effectiveness (VE) of ABRYSVO vaccination during pregnancy against RSV-associated outcomes in infants. The study will take place in a real-world population in Western Pennsylvania over multiple seasons, beginning in the 2023-2024 season, and will use a test negative design (TND approach).
There will be no active enrollment of study participants, no direct contact with study participants, and no collection of any primary data outside of the Standard of Care (SOC).

This study will use a TND to evaluate real-world VE of maternal ABRYSVO against RSV-associated outcomes in infants. Additionally, we will describe RSV-associated medically-attended visits for infants exposed to ABRYSVO and Beyfortus (monoclonal antibody (MAB) administered to babies up to 24 months for protection against RSV).

Study status

Planned
Research institutions and networks

Institutions

University of Pittsburgh

Contact details

Anne-Marie Rick

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study 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, Inc
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable