mRNA-1273-P920, Post-marketing safety of elasomeran/davesomeran and andusomeran vaccines in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106695
• EU PAS number:
  EUPAS106694
• Study ID:
  106695
• Official title and acronym:
  mRNA-1273-P920, Post-marketing safety of elasomeran/davesomeran and andusomeran vaccines in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective cohort study of adults and children identified in US administrative claims data, a source of secondary data. The observed rates of AESI among patients who receive at least one dose of the Elasomeran/Davesomeran and Andusomeran vaccine will be compared to two concurrent comparator groups utilizing two separate cohorts.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual: 31/01/2022

Study start date

Actual: 14/04/2023

Data analysis start date

Actual: 14/04/2023

Date of interim report, if expected

Actual: 15/09/2023

Date of final study report

Planned: 15/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ModernaTX Inc

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)