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

Contact details

Clinical Trial Disclosure ModernaTX

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Actual:
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)