Study identification

EU PAS number

EUPAS1000000750

Study ID

1000000750

Official title and acronym

​​Observational Study to Assess Pregnancy and Infant Outcomes Following Exposure to Updated Moderna Vaccines Targeting SARS CoV-2 During Pregnancy​

DARWIN EU® study

No

Study countries

United States

Study description

​​The aim of this study is to assess whether receipt of updated Spikevax formulations (mRNA-1273.222 or mRNA-1273.815) during pregnancy is associated with an increased rate of pregnancy complications, adverse pregnancy outcomes, or adverse infant outcomes.
The secondary objectives of this study are to assess whether exposure to Spikevax during pregnancy is associated with a change in rate of infant hospitalization due to COVID-19 in the first 6 months of life and to describe Spikevax utilization during pregnancy.​

Study status

Ongoing
Research institutions and networks

Institutions

​​Optum Insight Life Sciences​

Networks

​​Optum Insight Life Sciences​

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

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

ModernaTX
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable