Purpose

The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19. - Understands and agrees to comply with the study procedures and provides written informed consent. - Able to comply with study procedures based on the assessment of the Investigator. - Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status. - 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 Screening and on the day of the first dose (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 (Day 1). - Has agreed to continue adequate contraception through 3 months following the second dose on Day 29. - Is not currently breastfeeding. - Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. Additional Inclusion Criteria for Part B: Participants who were previously enrolled in the mRNA-1273-P301 study and chose to be unblinded.

Exclusion Criteria

  • Is acutely ill or febrile 72 hours prior to or at Screening. Fever is defined as a body temperature ≥38.0°Celsius/100.4°Fahrenheit. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator. - Is pregnant or breastfeeding. - (Part A Only) Known history of SARS-CoV-2 infection. - Prior administration of an investigational coronavirus (SARS-CoV, Middle East Respiratory Syndrome [MERS]-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19. - (Part A Only) Demonstrated inability to comply with the study procedures. - (Part A Only) An immediate family member or household member of this study's personnel. - Known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. - Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. - Has received or plans to receive a vaccine within 28 days prior to the first dose (Day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (except for seasonal influenza vaccine). - Has participated in an interventional clinical study within 28 days prior to the day of enrollment. - Immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, and recurrent severe infections. - Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). - Has received systemic immunoglobulins or blood products within 3 months prior to the day of Screening. - Has donated ≥450 milliliters (mL) of blood products within 28 days prior to Screening.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Part A is observer-blind. During Part B participants may request to be unblinded by scheduling a Participant Decision clinic visit.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
mRNA-1273
Part A: Participants will receive 1 intramuscular (IM) injection of 100 microgram (ug) mRNA-1273 on Day 1 and on Day 29. Part B: Participants who choose to be unblinded and received mRNA-1273-matching placebo during Part A, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and Day 29, if the participant chooses. Participants who choose to be unblinded and was only able to receive 1 dose of mRNA-1273 due to administrative reasons, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1, if the participant chooses.
  • Biological: mRNA-1273
    Sterile liquid for injection
  • Biological: Placebo
    0.9% sodium chloride (normal saline) injection
Placebo Comparator
Placebo
Part A only: Participants will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29, if the participant chooses.
  • Biological: Placebo
    0.9% sodium chloride (normal saline) injection

More Details

Status
Active, not recruiting
Sponsor
ModernaTX, Inc.

Study Contact

Detailed Description

This is a 2-part Phase 3 study, with Part A (Blinded Phase) and Part B (Open-label Observational Phase). Participants in Part A are blinded to their treatment assignment, with participants receiving either 2 active mRNA-1273 vaccine doses or placebo. Part B of the study is designed to offer participants to be unblinded so that participants who received placebo in Part A can request 2 doses of open-label mRNA-1273 vaccine. Additionally, participants who choose to be unblinded and was only able to receive 1 dose of mRNA-1273 due to administrative reasons, can choose to receive the second dose of mRNA-1273 during Part B. Please access www.modernatx.com/cove-study for additional information, such as Study Overview, Participation, and Site Locations along with contact numbers for each location for the study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.