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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06369272
Other study ID # mRNA-1273-P919
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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