A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
ModernaTX, Inc.
Study ID
NCT07089706
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • mRNA-1283.251 Variant-containing Formulation — BIOLOGICAL
    Sterile liquid for injection

Study Details

The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.

Key Dates

Start date
Jul 21, 2025
Status verified
May 2026
Primary completion
Jun 19, 2026
Completion
Jun 19, 2026

Study Design

Enrollment
832 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: mRNA-1283.251 Variant-containing Formulation
    Participants will receive an intramuscular (IM) injection of a mRNA-1283.251 variant-containing formulation.

Primary Outcome Measure

Subprotocol 1: Part A - Geometric Mean (GM) Value of Neutralizing Antibody (nAb) Against Vaccine-matched COVID-19 Variants [ Time Frame: Day 29 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
DelRicht Research-AtlantaAtlantaGeorgia30329-
DelRicht Research-Baton RougeBaton RougeLouisiana70769-
DelRicht Research-New OrleansNew OrleansLouisiana70115-
DelRicht Research-GulfportGulfportMississippi39503-
DelRicht Research-TulsaTulsaOklahoma74133-

Find similar trials in Atlanta, GA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
DelRicht Research-Atlanta· Atlanta, GADelRicht Research-Baton Rouge· Baton Rouge, LADelRicht Research-New Orleans· New Orleans, LADelRicht Research-Gulfport· Gulfport, MSDelRicht Research-Tulsa· Tulsa, OK

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