mRNA-1273-P901, Real-World Study of the Effectiveness of Moderna COVID-19 Vaccine

Study type

• Study type:
  Non-interventional study

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

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Estimated number of subjects:
  1000000

Study design details

• Main study objective:
  The primary objective of this study is to evaluate the vaccine effectiveness (VE) of receipt of Moderna COVID-19 vaccine in preventing SARS-CoV-2 infection and severe COVID-19 disease. SARS-CoV-2 infection will be defined as a positive antigen test result as well as a positive molecular diagnostic test among symptomatic or asymptomatic participants or a COVID-19 diagnosis code.
• Outcomes:
  1. Number of Participants With SARS-CoV-2 Infection 2. Number of Participants With Severe COVID-19 Disease
• Data analysis plan:
  Primary Objectives will be analyzed at interim and final analyses. Descriptive attributes of vaccinated and unvaccinated cohorts will be presented as absolute no. and %. χ2 test will be used to test for significant differences in the distribution of the categorical covariates among individuals between each of the vaccinated and unvaccinated cohorts at cohort entry. Continuous variables will be presented as the mean with standard deviation and/or median with interquartile ranges, with p-values for the two-sample test or Wilcoxon rank-sum test, as appropriate. Absolute standardized differences will be calculated to assess the balance of covariates. Overall incidence rates of SARS-CoV-2 infection and of severe COVID-19 for the vaccinated and unvaccinated cohorts will be calculated by dividing the no. of incident events by the total no. of person-yrs. Vaccine Effectiveness will be estimated using Cox Proportional Hazards and Logistic Regression methods where appropriate.