mRNA Vaccines for COVID-19

Not yet recruiting at 148 trial locations

Overseen By Moderna WeCare Team

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: ModernaTX, Inc.

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This clinical trial is for adults aged 50 to 64 who are not at high risk for severe COVID-19. Participants will be testing two variant formulations of mRNA vaccines, aiming to see how well they work and their safety profile.

Inclusion Criteria

I am healthy with no conditions that increase my COVID-19 risks, confirmed by medical tests.

Exclusion Criteria

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, 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

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1283
• mRNA-1273

Trial Overview The study is comparing the effectiveness and safety of two mRNA vaccines: mRNA-1283 and mRNA-1273. Some participants will receive a placebo instead. The goal is to determine if these vaccines can prevent COVID-19 in the specified age group without high-risk conditions.

How Is the Trial Designed?

Group I: mRNA-1283 (Variant Formulation) Experimental Treatment 1 Intervention

Participants will receive a single IM injection of mRNA-1283 on Day 1.

Group II: mRNA-1273 (Variant Formulation) Experimental Treatment 1 Intervention

Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive a single IM injection of placebo on Day 1.

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris