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

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

Study timelines

Date when funding contract was signed

Planned:12/07/2024

Actual:25/07/2024

Study start date

Planned:12/08/2024

Actual:26/08/2024

Date of final study report

Planned:15/04/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

No information provided.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

C3671068