mRNA-1273-P919: An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy

Study identification

• EU PAS number:
  EUPAS1000000058
• Study ID:
  1000000058
• Official title and acronym:
  mRNA-1273-P919: An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This observational post-marketing safety study is designed to evaluate the risk of adverse pregnancy outcomes, birth outcomes, infant outcomes, or early life infections following maternal exposure to Spikevax during pregnancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

Carelon Research

Study timelines

Date when funding contract was signed

Actual: 02/11/2022

Study start date

Actual: 28/10/2023

Data analysis start date

Actual: 01/03/2023

Date of final study report

Actual: 29/03/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Moderna TX, 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)

Other study registration identification numbers and links

mRNA-1273-P919