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NCT05815498 · ClinicalTrials.gov registry record · Phase 3
A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19
A Phase 3 study of COVID-19, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 3
- Development phase
- 14,246
- Enrollment target
- 20
- Study locations
NCT05815498: Completed Phase 3 study of COVID-19, sponsored by ModernaTX.
NCT05815498 is a Phase 3 study of COVID-19 that has completed, run by ModernaTX. The registered enrollment target is 14,246 participants, below the 38,417-participant average among 298 other COVID-19 trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05815498, a Phase 3 study of COVID-19, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 14,246 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2).
Primary Outcome
Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 103 arbitrary units (AU)/milliliter (mL) and ULOQ was 28571 AU/mL.
Conditions Studied
Interventions
- BIOLOGICAL mRNA-1283.222
- BIOLOGICAL mRNA-1273.222
- BIOLOGICAL mRNA-1283.815
- BIOLOGICAL mRNA-1273.815
Study Locations (20)
California
- Anaheim Clinical Trials, LLC - Anaheim
- Velocity Clinical Research, Banning - Banning
- Velocity Clinical Research- Chula Vista - Chula Vista
- Benchmark Research - Colton
- Marvel Clinical Research 002, LLC - Huntington Beach
- Velocity Clinical Research Huntington Park - Huntington Park
- Velocity Clinical Research - La Mesa
- Chemidox Clinical Trials - Lancaster
- Long Beach Clinical Trials - Long Beach
- Velocity Clinical Research- Westlake - Los Angeles
Arizona
- Chandler Clinical Trials - Chandler
- Phoenix Clinical Research LLC - Phoenix
- FRC - CCT Research - Phoenix
- Headlands Research Sarasota - Scottsdale
- Clinical Research Consortium - Tempe
- Noble Clinical Research, LLC - Tucson
- Del Sol research Management LLC. - Tucson
Alabama
- Optimal Research - Huntsville
- Accel Research Sites- Achieve Clinical Research - Vestavia Hills
Arkansas
- Lynn Institute of the Ozarks - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,246 participants |
| Start Date | 2023-03-28 |
| Est. Completion | 2025-04-12 |
| Phase | Phase 3 |
What the finished NCT05815498 record still lists
NCT05815498 is an interventional study that assigns participants to a tested intervention. Its 14,246 participants enrollment target places it among the larger protocols in the corpus, below the 38,417-participant average among 298 other COVID-19 trials with a reported enrollment target (63% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 4 interventions - of which mRNA-1283.222 is the first listed.
NCT05815498 names 20 study sites across 4 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05815498 about?
NCT05815498 is a clinical study titled "A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19". The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2).
What is the current status of trial NCT05815498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 14,246 participants. The study started on 2023-03-28. Estimated completion is 2025-04-12.
What conditions does trial NCT05815498 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT05815498?
The interventions under investigation include: mRNA-1283.222 (BIOLOGICAL), mRNA-1273.222 (BIOLOGICAL), mRNA-1283.815 (BIOLOGICAL), mRNA-1273.815 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05815498?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05815498 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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14,246 23rd of 298 higher than 276 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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