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

NCT06369272 | Completed

• 1 other identifier: mRNA-1273-P919
• Study Type: observational
• Target: 1,192
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Outcomes; Infant Outcomes; Pregnancy

Keywords

Maternal outcomes; Infant outcomes; Pregnancy; Observational; SPIKEVAX

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• 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

Study Arms (4)

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.

Eligibility Criteria

• Age: 13 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (1)

Carelon Research

Newton, Massachusetts, 02458, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: March 1, 2023
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

US (1)