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

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
ModernaTX, Inc.
Study ID
NCT07863635
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • mRNA-1273 — BIOLOGICAL
    Sterile liquid for injection
  • mRNA-1283 — BIOLOGICAL
    Sterile liquid for injection

Study Details

The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment

Key Dates

First listed
Oct 7, 2026
Start date
Oct 9, 2026
Status verified
Sep 2026
Primary completion
Jan 9, 2027
Completion
Jan 9, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: mRNA-1273 (Variant Formulation)
    Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1.
  • Experimental: mRNA-1283 (Variant Formulation)
    Participants will receive a single IM injection of mRNA-1283 on Day 1.

Primary Outcome Measure

Geometric Mean Titer (GMT) on Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation [ Time Frame: Day 29 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Delricht Research @ Concierge and Direct Primary CareOverland ParkKansas66209-
Delricht Research @ Derby City Direct Primary CareLouisvilleKentucky40205-
Delricht Research @ Olabisi BadmusCharlotteNorth Carolina28210-
Delricht Research @ Magnolia Family MedicineHendersonvilleTennessee37075-
Delricht Research @ Zomnir Family MedicineProsperTexas75078-

Find similar trials in Overland Park, KS

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By specialty
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By research site
Delricht Research @ Concierge and Direct Primary Care· Overland Park, KSDelricht Research @ Derby City Direct Primary Care· Louisville, KYDelricht Research @ Olabisi Badmus· Charlotte, NCDelricht Research @ Magnolia Family Medicine· Hendersonville, TNDelricht Research @ Zomnir Family Medicine· Prosper, TX

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