Moderna mRNA-1273 Observational Pregnancy Outcome Study (COVID-19)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  The Moderna COVID-19 Vaccine Pregnancy Registry will collect primary data from pregnant women who have received the Moderna COVID-19 vaccine and their healthcare providers

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ELASOMERAN

  IMELASOMERAN
• Medical condition to be studied:
  Multiple congenital abnormalities
• Additional medical condition(s):
  Preeclampsia, eclampsia, pregnancy-induced hypertension, antenatal bleeding, preterm labor, gestational diabetes, dysfunctional labor, premature rupture of membranes, placenta previa, postpartum hemorrhage, small–for–gestational-age (SGA) fetus and intrauterine growth restriction, and non-reassuring fetal status. Spontaneous abortions, fetal death or stillbirth and COVID-19 diagnosis.

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The main goal of this study is to evaluate the outcomes of pregnancy in females exposed to the Moderna COVID-19 vaccine (mRNA-1273) during pregnancy.
• Outcomes:
  1. Number of Participants Having Infants With Suspected Major and Minor Congenital Malformations. 2. Number of Participants With Any Pregnancy Complications 3. Number of Participants With Any Pregnancy Outcomes 4. Number of Participants With Infant Outcomes
• Data analysis plan:
  Descriptive analyses will be performed to gain an understanding of the qualitative and quantitative nature of the data collected and the characteristics of the sample studied. Continuous variables will be reported as mean (and standard deviation) or median and range where appropriate. Categorical variables will be summarized as number and proportion of the total study population, and by subgroups where appropriate. The study will evaluate the proportion of major congenital malformations in infants of women exposed to the Moderna COVID-19 vaccine at any point from 28 days prior to LMP through pregnancy as well other maternal, fetal, and infant outcomes variables identified for the subgroup analysis will be evaluated as potential confounders in the comparative analysis of the risk ratio for major congenital malformations in the Moderna COVID-19 vaccine exposed and external comparator (when possible).