COVID-19 Vaccine mRNA-1273 Define-XML Dataset Definitions
These Define-XML files contain comprehensive metadata documentation for Moderna's mRNA-1273 COVID-19 vaccine clinical trial datasets submitted to FDA under BLA 125752. Each file provides detailed information about dataset structures, variables, controlled terminology, and computational methods used in the P201 and P301 (COVE) trials.
| Authorization | Study/Protocol | Phase | Data Type | Description | File Links |
|---|
Study P201: Phase 2a dose-ranging study evaluating safety and immunogenicity of mRNA-1273 at different dose levels.
Study P301 (COVE): Phase 3 pivotal efficacy trial evaluating the efficacy, safety, and immunogenicity of mRNA-1273 in preventing COVID-19.
ADaM (Analysis Data Model): Contains analysis-ready datasets used for statistical analysis and regulatory submissions.
SDTM (Study Data Tabulation Model): Contains raw clinical trial data in a standardized format following CDISC standards.