A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- ModernaTX, Inc.
- Study ID
- NCT06585241
- Phase
- PHASE4
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Months - N/A
- Healthy Volunteers
- Accepted
Interventions
- mRNA-1273 Variant-containing Formulation — BIOLOGICALSterile liquid for injection
Study Details
The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Key Dates
- Start date
- Sep 9, 2024
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 1,144 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: mRNA-1273 Variant-containing FormulationParticipants will receive intramuscular (IM) injection(s) of an mRNA-1273 variant-containing formulation (mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, or mRNA-1273.261).
Primary Outcome Measure
mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Value of Neutralizing Antibody Against COVID-19 Variants [ Time Frame: Up to Day 29 ]
Central Contacts
- Moderna WeCare Team1-866-663-3762
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| CenExel | Atlanta | Georgia | 30331 | - |
| CenExel | Decatur | Georgia | 30030 | - |
| Velocity Clinical Research | Baton Rouge | Louisiana | 70809 | - |
| Velocity Clinical Research | Gulfport | Mississippi | 39503 | - |
| Velocity Clinical Research | Omaha | Nebraska | 68134 | - |
| Richard Bennett - Clinical Research Partners | Richmond | Virginia | 23226 | - |
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