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

SARS-CoV-2 Clinical Trial

Official title:

Moderna mRNA-1273 Observational Pregnancy Outcome Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04958304
• Other study ID #: mRNA-1273-P902
• Status: Terminated
• Start date: September 1, 2021
• Est. completion date: September 22, 2023

Study information

• Verified date: November 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

The Moderna COVID-19 Vaccine Pregnancy Registry will collect and analyze information on the potential impact of exposure to the Moderna COVID-19 vaccine on pregnancy and birth outcomes.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• SARS-CoV-2

Locations

Country	Name	City	State
United States	IQVIA Call Center for United States and Canada	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Having Infants With Suspected Major and Minor Congenital Malformations	Major malformations are those that have significant medical, social or cosmetic consequences, and typically require surgical intervention or are life-threatening (for example, cleft lip, spina bifida).	Up to 1 year of infant age
Primary	Number of Participants With Any Pregnancy Complications	Pregnancy complications may include preeclampsia, eclampsia, pregnancy-induced hypertension, antenatal bleeding, preterm labor, gestational diabetes, dysfunctional labor, premature rupture of membranes, placenta previa, postpartum hemorrhage, small-for-gestational-age (SGA) fetus and intrauterine growth restriction (IUGR), and non-reassuring fetal status.	From end of first trimester (approximately 14 weeks) up to mid-third trimester (approximately 34 weeks)
Primary	Number of Participants With Any Pregnancy Outcomes	Pregnancy outcomes may include spontaneous abortions, fetal death or stillbirth, live birth, elective or therapeutic pregnancy terminations, preterm birth, ectopic pregnancies, molar pregnancies, maternal death, and COVID-19 diagnosis.	Approximately 4 weeks after expected date of delivery (EDD)
Primary	Number of Participants With Infant Outcomes	Infant outcomes may include minor congenital malformations, size of gestational age, low birth weight, size for age, failure to thrive, hospitalization of infants, neonatal death, perinatal death, neonatal encephalopathy, respiratory distress in the newborn, neonatal/infant infection, infant death, and infant developmental milestones.	Up to 1 year of infant age