An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy

ModernaTX, Inc.1 site in 1 country1,192 target enrollmentMarch 1, 2023

ConditionsMaternal Outcomes Infant Outcomes Pregnancy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Maternal Outcomes
Sponsor: ModernaTX, Inc.
Enrollment: 1192
Locations: 1
Primary Endpoint: Number of Adverse Neonatal and Infant Outcomes
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objectives of this study are:

In infants of women exposed to SPIKEVAX during pregnancy, to assess:

If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs).
If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of adverse neonatal and infant outcomes, specifically neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, and incidence of hospitalization due to infections including coronavirus disease 2019 (COVID-19).
In women exposed to SPIKEVAX during pregnancy, to assess whether exposure to SPIKEVAX is associated with an increased prevalence of hypertensive disorders [e.g., pre-eclampsia, eclampsia, and gestational hypertension] gestational diabetes, and post-partum hemorrhage; and
To assess whether exposure to SPIKEVAX during pregnancy is associated with an increased incidence of stillbirth, preterm birth, and medically attended spontaneous abortion.

Registry

clinicaltrials.gov

Start Date

March 1, 2023

End Date

October 20, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

ModernaTX, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•EOP within study period
•Continuous enrollment in a health plan contributing to the HealthCare Integrated Research Database℠ (HIRD) database for at least 90 days prior to the estimated LMP.

Exclusion Criteria

•Exposure to any non-Moderna COVID-19 vaccines at any time prior to LMP and from LMP through the exposure ascertainment period for the outcome of interest. However, pregnant women exposed to other non-Moderna vaccines in addition to SPIKEVAX will be included in a sensitivity analysis.
•Instances where the outcome of a pregnancy is not documented (e.g., a prenatal care claim is followed by no further documentation of pregnancy, termination, or delivery where the participant remains enrolled in the health plan) may also be observed. The number of these possibly exposed pregnancies will be tabulated and described; however, they will not be included in the descriptive or comparative analyses.

Outcomes

Primary Outcomes

Number of Adverse Neonatal and Infant Outcomes

Time Frame: Up to approximately 3 years

Adverse neonatal and infant outcomes include neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, or incidence of hospitalization due to infections including COVID-19.

Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions

Time Frame: Up to approximately 3 years

Number of MCMs

Time Frame: Up to approximately 3 years

Number of Participants with Hypertensive Disorders

Time Frame: Up to approximately 3 years

Hypertensive disorders include pre-eclampsia, eclampsia, and gestational hypertension, gestational diabetes, or post-partum hemorrhage

Secondary Outcomes

Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations(Baseline)
Demographics: Age at LMP(Baseline)
Demographics: Participant Socio-economic Status(Baseline)
Demographics: Participant Region of Residence(Baseline)
Demographics: Number of Overweight or Obese Participants(Baseline)
Demographics: Duration of Health Plan Enrolment Prior to Pregnancy(Baseline)
Demographics: Calendar Date of the Pregnancy Outcome(Baseline)
Demographics: Participant Race and Ethnicity(Baseline)
Healthcare Utilization: Number of Distinct Medications Used(Baseline)