Study identification

EU PAS number

EUPAS1000000224

Study ID

1000000224

Official title and acronym

Real World Impact and Effectiveness of ABRYSVO Vaccination During Pregnancy Against RSV Illness in Infants (BERNI)

DARWIN EU® study

No

Study countries

Argentina
Uruguay

Study description

This study will be conducted in collaboration with a research network comprised of independent hospital sites across Argentina and Uruguay to evaluate the vaccine effectiveness (VE) and impact of ABRYSVO vaccination during pregnancy in a real-world population over multiple seasons, beginning in 2024 in Argentina and beginning in 2025 in Uruguay. We will use three retrospective design approaches in this study:
(i) a test negative design (TND) to evaluate real-world VE of maternal ABRYSVO against RSV-associated outcomes in infants;
(ii) a descriptive cohort design to evaluate the clinical evolution of infants hospitalized with RSV-positive lower respiratory tract disease (LRTD) by maternal ABRYSVO status; and
(iii) an ecologic before-and-after design to evaluate the population-level impact of ABRYSVO vaccination during pregnancy on infant RSV-associated and all-cause respiratory outcomes.

Study status

Ongoing
Research institutions and networks

Institutions

iTRIALS

Networks

iTRIALS

Contact details

Gonzalo Perez Marc

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable