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 — BIOLOGICAL
    Sterile 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 Formulation
    Participants 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

Locations (6)

FacilityCityStateZIPSite coordinators
CenExelAtlantaGeorgia30331-
CenExelDecaturGeorgia30030-
Velocity Clinical ResearchBaton RougeLouisiana70809-
Velocity Clinical ResearchGulfportMississippi39503-
Velocity Clinical ResearchOmahaNebraska68134-
Richard Bennett - Clinical Research PartnersRichmondVirginia23226-

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