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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06369272
• Other study ID #: mRNA-1273-P919
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: April 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1192
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	Carelon Research	Newton	Massachusetts

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 MCMs		Up to approximately 3 years
Primary	Number of Adverse Neonatal and Infant Outcomes	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.	Up to approximately 3 years
Primary	Number of Participants with Hypertensive Disorders	Hypertensive disorders include pre-eclampsia, eclampsia, and gestational hypertension, gestational diabetes, or post-partum hemorrhage	Up to approximately 3 years
Primary	Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions		Up to approximately 3 years
Secondary	Demographics: Participant Region of Residence		Baseline
Secondary	Demographics: Age at LMP		Baseline
Secondary	Demographics: Number of Overweight or Obese Participants		Baseline
Secondary	Demographics: Duration of Health Plan Enrolment Prior to Pregnancy		Baseline
Secondary	Demographics: Calendar Date of the Pregnancy Outcome		Baseline
Secondary	Demographics: Participant Race and Ethnicity		Baseline
Secondary	Demographics: Participant Socio-economic Status		Baseline
Secondary	Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations		Baseline
Secondary	Healthcare Utilization: Number of Distinct Medications Used		Baseline