Trials / Completed
CompletedNCT04958954
Post-Marketing Safety Study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in the United States
Post-Marketing Safety of SARS-CoV-2 mRNA-1273 Vaccine in the US: Active Surveillance, Signal Refinement and Self-Controlled Risk Interval (SCRI) Signal Evaluation in HealthVerity
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50,000,000 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.
Detailed description
This retrospective observational cohort study will use secondary, de-identified individual-level medical and pharmacy claims data provided by HealthVerity.
Conditions
Timeline
- Start date
- 2021-07-07
- Primary completion
- 2022-08-31
- Completion
- 2023-06-30
- First posted
- 2021-07-12
- Last updated
- 2023-07-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04958954. Inclusion in this directory is not an endorsement.