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

Moderna

Status: Completed

Conditions: Infant Outcomes; Maternal Outcomes; Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT06369272

mRNA-1273-P919

Details and patient eligibility

About

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.

Enrollment: 1,192 patients

Sex: Female

Ages: 13 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,192 participants in 4 patient groups

SPIKEVAX Exposed Pregnancy

Description:

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

Description:

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

Description:

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

Description:

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.