A Post-Marketing Safety Study to Evaluate the Safety of Respiratory Syncytial Virus Vaccine (ABRYSVO™) Exposure During Pregnancy in an Integrated Healthcare System in the United States (C3671042)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001074
• Study ID:
  1000001074
• Official title and acronym:
  A Post-Marketing Safety Study to Evaluate the Safety of Respiratory Syncytial Virus Vaccine (ABRYSVO™) Exposure During Pregnancy in an Integrated Healthcare System in the United States (C3671042)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The overall research question is: what is the risk of preterm birth, hypertensive disorders of; pregnancy, and other pre-specified adverse pregnancy, maternal, and neonatal/infant outcomes following exposure to respiratory syncytial virus prefusion F vaccine (RSVpreF) [Brand name: ABRYSVO™] during pregnancy? The primary objective is to estimate the risk of (1) preterm birth, and (2) hypertensive disorders of pregnancy following exposure to ABRYSVO™ during pregnancy.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Kaiser Permanente Northern California (KPNC)

Study timelines

Date when funding contract was signed

Planned:30/05/2024

Actual:30/05/2024

Study start date

Planned:30/09/2026

Data analysis start date

Planned:09/09/2028

Date of interim report, if expected

Planned:31/03/2027

Date of final study report

Planned:08/03/2029

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

C3671042