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Recruiting Phase 4 NCT06585241

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

Trial Parameters

Condition SARS-CoV-2
Sponsor ModernaTX, Inc.
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 1,144
Sex ALL
Min Age 6 Months
Max Age N/A
Start Date 2024-09-09
Completion 2026-12-31
Interventions
mRNA-1273 Variant-containing Formulation

Brief Summary

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).

Eligibility Criteria

Key Inclusion Criteria: * mRNA-1273.167 and mRNA-1273.712: Previously vaccinated adults aged ≥18 years * mRNA-1273.251: Participants ≥65 years of age, ≥12 to \<65 years of age, or ≥6 months to \<12 years of age with at least 1 risk factor for severe outcomes from COVID-19. * mRNA-1273.261: ≥65 years of age at the time of signing the informed consent or ≥18 to \<65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19. * Able to comply with study procedures based on the assessment of the Investigator. * Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: * Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1. * Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose. * Has a

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