SARS-CoV-2
Conditions
Keywords
mRNA-1273, mRNA-1283, SARS-CoV-2, mRNA vaccine, Coronavirus, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Brief summary
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.
Interventions
BIOLOGICALmRNA-1273
Sterile liquid for injection
BIOLOGICALmRNA-1283
Sterile liquid for injection
BIOLOGICALPlacebo
0.9% sodium chloride (normal saline) injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VE of mRNA-1273 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection | 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). |
| Vaccine Efficacy (VE) of mRNA-1283 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection | 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). |
| Number of Participants with Unsolicited Adverse Events (AEs) | Day 1 through Day 28 | — |
| Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation | Day 1 through Day 181 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with a First Event of Severe COVID-19 after Study Injection | Day 1 through Day 181 |
Countries
United States
Outcome results
None listed