Safety Profile of the NVX-CoV2373 Vaccine in Individuals ≥ 12 Years of Age in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104623
• EU PAS number:
  EUPAS104622
• Study ID:
  104623
• Official title and acronym:
  Safety Profile of the NVX-CoV2373 Vaccine in Individuals ≥ 12 Years of Age in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Ongoing

Research institution and networks

Institutions

Jessica Citronberg

Study timelines

Date when funding contract was signed

Planned: 18/12/2021

Actual: 18/12/2021

Study start date

Planned: 31/03/2023

Actual: 31/03/2023

Date of final study report

Planned: 30/09/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novavax, 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)