A Post-Authorization Safety Study of Guillain-Barré Syndrome (GBS) Following ABRYSVOTM Among Older Adults in the United States (C3671031)

Study identification

• EU PAS number:
  EUPAS1000000753
• Study ID:
  1000000753
• Official title and acronym:
  A Post-Authorization Safety Study of Guillain-Barré Syndrome (GBS) Following ABRYSVOTM Among Older Adults in the United States (C3671031)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This non-interventional post authorization safety study (PASS) will assess the risk of Guillain-Barré Syndrome (GBS), acute polyneuropathies, and other immune-mediated demyelinating conditions following receipt of ABRYSVO among US Medicare beneficiaries 65 years of age and older, as well as commercially insured adults aged 60-64 years, from the earliest date of vaccine availability to 31 December 2027.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Analysis Group

Study timelines

Date when funding contract was signed

Planned:02/06/2023

Actual:02/06/2023

Study start date

Planned:28/02/2026

Data analysis start date

Planned:01/06/2029

Date of interim report, if expected

Planned:18/12/2026

Date of final study report

Planned:31/05/2030

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)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

C3671031