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History of Changes for Study: NCT04470427
A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19
Latest version (submitted January 11, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 11, 2020 None (earliest Version on record)
2 July 27, 2020 Recruitment Status, Contacts/Locations and Study Status
3 July 28, 2020 Contacts/Locations and Study Status
4 July 29, 2020 Contacts/Locations and Study Status
5 August 18, 2020 Study Status and Contacts/Locations
6 August 19, 2020 Study Status
7 August 19, 2020 Contacts/Locations and Study Status
8 August 24, 2020 References, Contacts/Locations, Study Description and Study Status
9 August 27, 2020 Contacts/Locations and Study Status
10 August 31, 2020 Contacts/Locations and Study Status
11 September 3, 2020 Study Status and References
12 September 5, 2020 Contacts/Locations and Study Status
13 September 25, 2020 Contacts/Locations and Study Status
14 October 27, 2020 Recruitment Status, Study Status and Contacts/Locations
15 February 11, 2021 Outcome Measures, Arms and Interventions, Study Design, Study Status, References, Eligibility and Study Description
16 February 23, 2021 Outcome Measures and Study Status
17 June 8, 2021 Study Status
18 November 29, 2021 Study Design, Study Status, Eligibility, Arms and Interventions and Study Description
19 December 18, 2021 Study Status
20 May 12, 2022 Study Status, Outcome Measures and Eligibility
21 January 11, 2023 Recruitment Status and Study Status
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Study NCT04470427
Submitted Date:  July 11, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: mRNA-1273-P301
Brief Title: A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19
Official Title: A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older
Secondary IDs: 75A50120C00034 [Other Grant/Funding Number: BARDA]
Open or close this module Study Status
Record Verification: July 2020
Overall Status: Not yet recruiting
Study Start: July 27, 2020
Primary Completion: October 27, 2022 [Anticipated]
Study Completion: October 27, 2022 [Anticipated]
First Submitted: July 11, 2020
First Submitted that
Met QC Criteria:
July 11, 2020
First Posted: July 14, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
July 11, 2020
Last Update Posted: July 14, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ModernaTX, Inc.
Responsible Party: Sponsor
Collaborators: Biomedical Advanced Research and Development Authority
National Institute of Allergy and Infectious Diseases (NIAID)
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 30000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: mRNA-1273
Participants will receive 1 intramuscular (IM) injection of 100 microgram (ug) mRNA-1273 on Day 1 and on Day 29.
Biological: mRNA-1273
Sterile liquid for injection
Placebo Comparator: Placebo
Participants will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
Biological: Placebo
0.9% sodium chloride (normal saline) injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of mRNA-1273
[ Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose) ]

2. Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal
[ Time Frame: Up to Day 759 (2 years after second dose) ]

3. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
[ Time Frame: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose) ]

4. Number of Participants with Unsolicited AEs
[ Time Frame: Up to Day 57 (28 days after each dose) ]

Secondary Outcome Measures:
1. Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of mRNA-1273
[ Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose) ]

Clinical signs indicative of severe COVID-19 as predefined for the study.
2. Number of Participants with a First Occurrence of Either COVID-19 or SARS-CoV-2 Infection regardless of symptomatology or Severity Starting 14 Days after Second Dose of mRNA-1273 or Placebo
[ Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose)] ]

Clinical signs indicative of COVID-19 and SARS-CoV-2 Infection as predefined for the study.
3. Number of Participants with a Secondary Case Definition of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo
[ Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose) ]

Clinical signs indicative of secondary case definition of COVID-19 as predefined for the study.
4. Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of mRNA-1273 or Placebo
[ Time Frame: Day 1 (first dose) up to Day 759 (2 years after second dose) ]

Clinical signs indicative of COVID-19 as predefined for the study.
5. Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo regardless of evidence of prior SARS-CoV-2 Infection
[ Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose) ]

Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.
6. Number of Participants with a First Occurrence of SARS-CoV-2 Infection in the Absence of Symptoms Defining COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo
[ Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose) ]

Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.
7. Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
[ Time Frame: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759 ]

8. Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb
[ Time Frame: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759 ]

9. Quantified Levels or GMT of S Protein-Specific Binding Antibody (bAb)
[ Time Frame: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759 ]

10. GMFR of S Protein Specific bAb
[ Time Frame: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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.
  • Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the time of the first dose and through 3 months after the second dose.
  • 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.

Exclusion Criteria:

  • Is acutely ill or febrile 72 hours prior to or at Screening. Fever is defined as a body temperature ≥38.0°C/100.4°F. 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.
  • 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.
  • Demonstrated inability to comply with the study procedures.
  • An immediate family member or household member of this study's personnel.
  • History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
  • 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). Topical tacrolimus is allowed if not used within 14 days prior to Screening.
  • 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.
Open or close this module Contacts/Locations
Central Contact Person: Moderna Clinical Trials
Telephone: 855-663-6762
Email: clinicaltrials@modernatx.com
Locations: United States, Alabama
Ascension St. Vincent Birmingham
Birmingham, Alabama, United States, 35205
United States, Arizona
Hope Research Institute
Chandler, Arizona, United States, 85224
Hope Research Institute
Peoria, Arizona, United States, 85018
Hope Research Institute
Phoenix, Arizona, United States, 85018
Quality of Life Medical and Research Center
Tucson, Arizona, United States, 85712
United States, Arkansas
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
United States, California
Advanced Clinical Research - Rancho Paseo
Banning, California, United States, 92220
University of California San Diego
La Jolla, California, United States, 92093
eStudySite - La Mesa
La Mesa, California, United States, 91942
UCLA Vine Street Clinic CRS
Los Angeles, California, United States, 90038
Paradigm Clinical Research Institute Inc
Redding, California, United States, 96001
Benchmark Research - Sacramento
Sacramento, California, United States, 95864
Medical Center For Clinical Research - M3 Wake Research
San Diego, California, United States, 92108
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Lynn Institute of The Rockies
Colorado Springs, Colorado, United States, 80918
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
Accel Research Site
DeLand, Florida, United States, 32720
Research Centers of America
Hollywood, Florida, United States, 33024
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Suncoast Research Group
Miami, Florida, United States, 33135
University of Miami
Miami, Florida, United States, 33136
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Hope Clinic of The Emory Vaccine Center
Decatur, Georgia, United States, 30030
Meridian Clinical Research
Savannah, Georgia, United States, 31406
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Illinois
UIC Project WISH CRS
Chicago, Illinois, United States, 60612
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
Alliance for Multispecialty Research
Newton, Kansas, United States, 67114
Alliance for Multispecialty Research- East Wichita
Wichita, Kansas, United States, 67207
United States, Louisiana
Meridian Clinical Research
Baton Rouge, Louisiana, United States, 70808
Benchmark Research - Metairie
Metairie, Louisiana, United States, 70006
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Meridian Clinical Research
Rockville, Maryland, United States, 20854
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Mississippi
MediSync Clinical Research Hattiesburg Clinic
Petal, Mississippi, United States, 39465
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
Sundance Clinical Research
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Meridian Clinical Research
Grand Island, Nebraska, United States, 68803
Meridian Clinical Research
Norfolk, Nebraska, United States, 68701
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89104
AB Clinical Trials
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
Meridian Clinical Research
Binghamton, New York, United States, 13901
Weill Cornell Chelsea - (CRS)
New York, New York, United States, 10010
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Tryon Medical Partners
Charlotte, North Carolina, United States, 28210
Carolina Institute for Clinical Research - M3 Wake Research
Fayetteville, North Carolina, United States, 28304
M3 Wake Research, Inc - M3 Wake
Raleigh, North Carolina, United States, 27612
Trial Management Associates
Wilmington, North Carolina, United States, 28403
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
New Horizons Clinical Research
Cincinnati, Ohio, United States, 45242
Cincinnati CRS
Cincinnati, Ohio, United States, 45267
Rapid Medical Research Inc
Cleveland, Ohio, United States, 44122
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Crisor
Medford, Oregon, United States, 97504
United States, Pennsylvania
Penn Prevention CRS
Philadelphia, Pennsylvania, United States, 19104
UPMC University Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Keystone VitaLink Research
Anderson, South Carolina, United States, 29621
Keystone VitaLink Research - Greenville
Greenville, South Carolina, United States, 29615
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
Keystone VitaLink Research - Spartanburg
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Meridian Clinical Research
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
WR-ClinSearch
Chattanooga, Tennessee, United States, 37421
Alliance for Multispecialty Research
Knoxville, Tennessee, United States, 39720
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Benchmark Research - Austin
Austin, Texas, United States, 78705
Tekton Research
Austin, Texas, United States, 78745
Advanced Clinical Research - Be Well MD
Cedar Park, Texas, United States, 78613
Global Medical Research - M3 Wake Research
Dallas, Texas, United States, 75224
Benchmark Research - Fort Worth
Fort Worth, Texas, United States, 76135
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
Baylor College of Medicine
Houston, Texas, United States, 77030
DM Clinical Research - Texas Center For Drug Development
Houston, Texas, United States, 77081
Laguna Clinical Research
Laredo, Texas, United States, 78041
Centex Studies
McAllen, Texas, United States, 78504
Benchmark Research - San Angelo
San Angelo, Texas, United States, 76904
Clinical Trials of Texas, Inc
San Antonio, Texas, United States, 78229
DM Clinical Research
Tomball, Texas, United States, 77375
United States, Utah
Foothill Family Clinic - North
Salt Lake City, Utah, United States, 84109
Foothill Family Clinic-South Clinic
Salt Lake City, Utah, United States, 84121
United States, Washington
Kaiser Permanente - Seattle
Seattle, Washington, United States, 98101
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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