Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study

Stopped early

Conditions studied: SARS-CoV-2

In brief

The main goal of this study is to evaluate the outcomes of pregnancy in females exposed to the Moderna COVID-19 vaccine (mRNA-1273) during pregnancy.

Key facts

Study ID

NCT04958304

Run by

ModernaTX, Inc.

People needed

20

Starts

2021-09-01

Expected to finish

2023-09-22

Last updated by the study team

2023-11-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Currently pregnant
• The outcome of pregnancy (that is, pregnancy loss or live birth) must not be known at entry.
• Agrees to electronically sign the release of medical information form permitting the study to contact her HCPs (for example, primary care provider [PCP], obstetrician, nurse midwife) and the infant's HCP (for example, pediatrician) for medical information.
• Received the Moderna COVID-19 vaccine at any point from 28 days prior to last menstrual period (LMP) throughout pregnancy.

You may not qualify if…

• Participant has received any other COVID-19 vaccines at any point from 28 days prior to LMP throughout pregnancy.
• Women currently participating in another investigational device or drug study, currently taking an investigational medicinal product, or having taken an investigational product within 28 days prior to LMP or during pregnancy.

Where it is running

• IQVIA Call Center for United States and Canada — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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