Trials / Recruiting
RecruitingNCT07266558
A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)
A Phase 4, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of mRNA-1283 And mRNA-1273 Variant-Containing Formulation in Adults 50 to 64 Years of Age Without Underlying Conditions That Put Them at High Risk for Severe Outcomes From COVID-19
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30,000 (estimated)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 50 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of mRNA-1283 and mRNA-1273 (variant formulations) in adults 50 to 64 years of age without high risk factors for severe COVID-19.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | mRNA-1273 | Sterile liquid for injection |
| BIOLOGICAL | mRNA-1283 | Sterile liquid for injection |
| BIOLOGICAL | Placebo | 0.9% sodium chloride (normal saline) injection |
Timeline
- Start date
- 2025-11-26
- Primary completion
- 2027-06-16
- Completion
- 2027-06-16
- First posted
- 2025-12-05
- Last updated
- 2026-03-12
Locations
150 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07266558. Inclusion in this directory is not an endorsement.