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Active, Not Recruiting

NCT Number: NCT07266558

A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)

The purpose of this study is to evaluate the efficacy and safety of mRNA-1283 and mRNA-1273 (variant formulations) in adults 50 to 64 years of age without high risk factors for severe COVID-19.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Accel Clinical Research, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Healthy and without underlying medical conditions that may put them at higher risk of experiencing severe outcomes of COVID-19, as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

Key Exclusion Criteria:

  • History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.
  • Acutely ill or febrile within 72 hours prior to or at the Screening Visit or Day 1.
  • Receipt of any of the following:
  • COVID-19 vaccine within 3 months prior to enrollment,
  • Any licensed non COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention,
  • Corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study or,
  • Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study.
  • Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days post study injection.
  • Has participated in an investigational clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Treatment and study plan

mRNA-1273

Biological

Sterile liquid for injection

mRNA-1283

Biological

Sterile liquid for injection

Placebo

Biological

0.9% sodium chloride (normal saline) injection

Primary outcomes

  1. VE of mRNA-1273 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection

    Time frame: Day 1 through Day 181

    The VE is defined as the percent reduction in the hazard of the first event of symptomatic COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).

  2. Vaccine Efficacy (VE) of mRNA-1283 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection

    Time frame: Day 1 through Day 181

    The VE is defined as the percent reduction in the hazard of the first event of symptomatic COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).

  3. Number of Participants with Unsolicited Adverse Events (AEs)

    Time frame: Day 1 through Day 28

  4. Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation

    Time frame: Day 1 through Day 181

Secondary outcomes

  1. Number of Participants with a First Event of Severe COVID-19 after Study Injection

    Time frame: Day 1 through Day 181

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

A Phase 4, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of mRNA-1283 And mRNA-1273 Variant-Containing Formulation in Adults 50 to 64 Years of Age Without Underlying Conditions That Put Them at High Risk for Severe Outcomes From COVID-19

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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