A Study of the Effectiveness of Moderna COVID-19 Vaccine
Completed
Conditions studied: SARS-CoV-2, COVID-19
In brief
This is an observational cohort study to evaluate real-world vaccine effectiveness and durability of Moderna COVID-19 vaccine among a diverse population at Kaiser Permanente Southern California (KPSC). 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. Severe COVID-19 disease will be defined as COVID-19 hospitalization or mortality.
Key facts
- Study ID
- NCT05933304
- Run by
- ModernaTX, Inc.
- People needed
- 927004
- Starts
- 2020-12-18
- Expected to finish
- 2023-11-17
- Last updated by the study team
- 2025-05-28
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Aged ≥18 years at index date (participants aged 6 months through 17 years will also be included after Food and Drug Administration [FDA] authorization to vaccinate younger age groups)
- KPSC member for ≥12 months prior to index date through 14 days after the index date (allowing a 31-day gap)
You may not qualify if…
- Receipt of a COVID-19 vaccine other than Moderna COVID-19 vaccine prior to or on the index date
- Receipt of 2 doses of Moderna COVID-19 vaccine <24 days apart for 2-dose exposed cohort
- Receipt of any COVID-19 vaccine <14 days after the index date
- No health care utilization and no vaccination from the 2 years prior to the index date through the index date
- Occurrence of a COVID-19 outcome <14 days after the index date
Where it is running
- Kaiser Permanente Southern California — Pasadena, California, United States
Full record on ClinicalTrials.gov
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