A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19

NCT ID: NCT04470427

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2022-12-29

Brief Summary

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.

Detailed Description

This is a 3-part Phase 3 study, with Part A (Blinded Phase), Part B (Open-label Observational Phase), and Part C (Booster Dose Phase). Participants in Part A are blinded to their treatment assignment, with participants receiving either mRNA-1273 vaccine 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 were 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. In Part C, a booster dose will be provided for all eligible participants who choose to receive one.

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.

Conditions

SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

mRNA-1273

Part A (Blinded): Participants will receive 1 intramuscular (IM) injection of 100 microgram (μg) mRNA-1273 on Day 1 and on Day 29.

Part B (Open-label): Participants who receive mRNA-1273-matching placebo during Part A and choose to be unblinded by participating in Part B, will receive 1 IM injection of 100 μg mRNA-1273 on Day 1 and Day 29. Participants who are only able to receive 1 dose of mRNA-1273 due to administrative reasons, will receive 1 IM injection of 100 μg mRNA-1273 on Day 1, if the participant chooses.

Part C: Eligible participants in Part B who choose to receive booster dose of mRNA-1273, will receive 1 IM injection of 50 μg mRNA-1273 on Day 1.

Group Type: EXPERIMENTAL

mRNA-1273

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Placebo

Intervention Type: BIOLOGICAL

0.9% sodium chloride (normal saline) injection

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Interventions

mRNA-1273

Sterile liquid for injection

Intervention Type: BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• (Part A only) 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, open-label Day 1, and booster 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 last dose (Day 29, open-label Day 29, and booster dose Day 1).
• 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.
• (Part C Only) Is currently enrolled in Part B of the current study (mRNA-1273-P301).
• (Part C Only) Has received at least 1 dose of mRNA-1273 in the current study (mRNA-1273-P301).

Exclusion Criteria

• Is acutely ill or febrile 72 hours prior to or at Screening or dosing (Part B and Part C). 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/dosed at the discretion of the Investigator.
• Is pregnant or breastfeeding.
• (Part A Only) Known history of SARS-CoV-2 infection.
• Prior (Part A) or concurrent (Part B and Part C) administration of non-study 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.
• 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 (IP) (except for seasonal influenza vaccine).
• (Part A only) 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 IP dose administration (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent).
• Has received systemic immunoglobulins or blood products within 3 months prior to the day of IP dose administration.
• Has donated ≥450 milliliters (mL) of blood products within 28 days prior to IP dose administration.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ascension St. Vincent Birmingham

Birmingham, Alabama, United States

Synexus Clinical Research US, Inc. - Birmingham

Birmingham, Alabama, United States

Hope Research Institute

Chandler, Arizona, United States

Synexus Clinical Research US, Inc. - Phoenix West

Glendale, Arizona, United States

Hope Research Institute

Peoria, Arizona, United States

Hope Research Institute

Phoenix, Arizona, United States

Quality of Life Medical and Research Center

Tucson, Arizona, United States

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Advanced Clinical Research - Rancho Paseo

Banning, California, United States

University of California San Diego

La Jolla, California, United States

eStudySite - La Mesa

La Mesa, California, United States

UCLA Vine Street Clinic CRS

Los Angeles, California, United States

VA Greater Los Angeles Healthcare (veterans only)

Los Angeles, California, United States

Paradigm Clinical Research Institute Inc

Redding, California, United States

Benchmark Research - Sacramento

Sacramento, California, United States

Medical Center For Clinical Research - M3 Wake Research

San Diego, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Lynn Institute of The Rockies

Colorado Springs, Colorado, United States

George Washington University

Washington D.C., District of Columbia, United States

Accel Research Site

DeLand, Florida, United States

Research Centers of America

Hollywood, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Synexus - Optimal Research - Melbourne

Melbourne, Florida, United States

Suncoast Research Group

Miami, Florida, United States

University of Miami

Miami, Florida, United States

Synexus Clinical Research US, Inc. - Orlando

Orlando, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Hope Clinic of The Emory Vaccine Center

Decatur, Georgia, United States

Meridian Clinical Research

Savannah, Georgia, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Synexus Clinical Research US, Inc. - Chicago

Chicago, Illinois, United States

UIC Project WISH CRS

Chicago, Illinois, United States

University of Chicago-Hospital

Chicago, Illinois, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Alliance for Multispecialty Research

Newton, Kansas, United States

Alliance for Multispecialty Research- East Wichita

Wichita, Kansas, United States

Meridian Clinical Research

Baton Rouge, Louisiana, United States

Benchmark Research - Metairie

Metairie, Louisiana, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Synexus - Optimal Research - Rockville

Rockville, Maryland, United States

Meridian Clinical Research

Rockville, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

MediSync Clinical Research Hattiesburg Clinic

Petal, Mississippi, United States

Saint Louis University

St Louis, Missouri, United States

Sundance Clinical Research

St Louis, Missouri, United States

Meridian Clinical Research

Grand Island, Nebraska, United States

Meridian Clinical Research

Norfolk, Nebraska, United States

Meridian Clinical Research

Omaha, Nebraska, United States

Clinical Research Center of Nevada

Las Vegas, Nevada, United States

AB Clinical Trials

Las Vegas, Nevada, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

New Jersey Medical School

Newark, New Jersey, United States

Meridian Clinical Research

Binghamton, New York, United States

Weill Cornell Chelsea - (CRS)

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Tryon Medical Partners

Charlotte, North Carolina, United States

Carolina Institute for Clinical Research - M3 Wake Research

Fayetteville, North Carolina, United States

M3 Wake Research, Inc - M3 Wake

Raleigh, North Carolina, United States

Trial Management Associates

Wilmington, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Synexus Clinical Research US, Inc. - Cincinnati

Cincinnati, Ohio, United States

New Horizons Clinical Research

Cincinnati, Ohio, United States

Cincinnati CRS

Cincinnati, Ohio, United States

Rapid Medical Research Inc

Cleveland, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Crisor

Medford, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

UPMC University Center

Pittsburgh, Pennsylvania, United States

Keystone VitaLink Research

Anderson, South Carolina, United States

Keystone VitaLink Research - Greenville

Greenville, South Carolina, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Keystone VitaLink Research - Spartanburg

Spartanburg, South Carolina, United States

Meridian Clinical Research

Dakota Dunes, South Dakota, United States

WR-ClinSearch

Chattanooga, Tennessee, United States

Alliance for Multispecialty Research

Knoxville, Tennessee, United States

Vanderbilt University Medical Center, Medical Arts Building

Nashville, Tennessee, United States

Vanderbilt University Medical Center, Medical Center North

Nashville, Tennessee, United States

Benchmark Research - Austin

Austin, Texas, United States

Synexus - Optimal Research - Austin

Austin, Texas, United States

Tekton Research

Austin, Texas, United States

Advanced Clinical Research - Be Well MD

Cedar Park, Texas, United States

Global Medical Research - M3 Wake Research

Dallas, Texas, United States

Synexus Clinical Research US, Inc. - Dallas

Dallas, Texas, United States

Benchmark Research - Fort Worth

Fort Worth, Texas, United States

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

DM Clinical Research - Texas Center For Drug Development

Houston, Texas, United States

Laguna Clinical Research

Laredo, Texas, United States

Centex Studies

McAllen, Texas, United States

Benchmark Research - San Angelo

San Angelo, Texas, United States

Clinical Trials of Texas, Inc

San Antonio, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Synexus Clinical Research US, Inc. - Salt Lake City

Murray, Utah, United States

Foothill Family Clinic - North

Salt Lake City, Utah, United States

Foothill Family Clinic-South Clinic

Salt Lake City, Utah, United States

Kaiser Permanente - Seattle

Seattle, Washington, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

75A50120C00034

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

mRNA-1273-P301

Identifier Type: -

Identifier Source: org_study_id