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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Maternal Outcomes; Infant Outcomes

• Study Type: Observational
• Enrollment (Actual): 1192

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Newton, Massachusetts, United States, 02458
      • Carelon Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study population includes women for whom an LMP can be successfully calculated based on a non-missing end of pregnancy (EOP), and who also meet the eligibility criteria to be included in the study analyses.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
SPIKEVAX Exposed Pregnancy; Cohort includes pregnant women who were vaccinated with SPIKEVAX from last menstrual period (LMP) through the exposure ascertainment period for the outcome of interest.
SPIKEVAX Distantly Exposed Pregnancy; Cohort includes pregnant women who were exposed to SPIKEVAX at least 60 days prior to LMP and not exposed to SPIKEVAX or any other COVID-19 vaccine from LMP through the exposure ascertainment period for the outcome of interest.
Unvaccinated During Pregnancy; Cohort includes pregnant women not exposed to SPIKEVAX or any other COVID-19 vaccine within 60 days prior to LMP through the exposure ascertainment period for the outcome of interest.
COVID-19 Infected During Pregnancy; Cohort includes pregnant women not exposed to SPIKEVAX or any other COVID-19 vaccine within 60 days prior to LMP through the exposure ascertainment period for the outcome of interest. These women also had at least one medically attended COVID-19 episode during the exposure ascertainment period outcome of interest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of MCMs		Up to approximately 3 years
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
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
Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions		Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Demographics: Participant Region of Residence	Baseline
Demographics: Age at LMP	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
Demographics: Participant Socio-economic Status	Baseline
Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations	Baseline
Healthcare Utilization: Number of Distinct Medications Used	Baseline

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): October 20, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Observational; Maternal outcomes; Infant outcomes; SPIKEVAX
• Other Study ID Numbers: mRNA-1273-P919