A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19
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
2 other identifiers
interventional
30,415
1 country
100
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2020
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2020
CompletedFirst Posted
Study publicly available on registry
July 14, 2020
CompletedStudy Start
First participant enrolled
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2022
CompletedResults Posted
Study results publicly available
March 21, 2024
CompletedMarch 21, 2024
March 1, 2024
2.4 years
July 11, 2020
December 21, 2023
March 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose
COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19. An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Dose
Solicited ARs (local and systemic) were collected in electronic diary (eDiary) within 7 days of dosing. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Severity grading for solicited ARs is based on modified Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. Severity was graded 0-4; a lower score indicated lower severity and a higher score indicated greater severity. The Investigator determined if solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
up to Day 7 (7 days after first dose)
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After Second Dose
Solicited ARs (local and systemic) were collected in eDiary within 7 days of dosing. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Severity grading for solicited ARs is based on modified Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. Severity was graded 0-4; lower score indicated lower severity and a higher score indicated greater severity. The Investigator determined if solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section
Day 29 to Day 35 (from second dose to 7 days after second dose)
Parts A and B: Number of Participants With Medically Attended AEs (MAAEs) and AEs Leading to Discontinuation
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Day 1 (after dosing) through end of study (up to Day 759)
Parts A and B: Number of Participants With Serious AEs (SAEs)
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Day 1 (after dosing) through end of study (up to Day 759)
Secondary Outcomes (15)
Part A: Number of Participants With Unsolicited AEs up to 28 Days After Any Injection Dose
Up to 28 days after any dose
Parts A and B: Number of Participants With a First Occurrence of Severe COVID-19 Starting 14 Days After Second Dose
From Day 43 (14 days after second dose) up to approximately 8 months for Part A and from PDV/unblinding (at 4 months) to up to 8 months for Part B
Part A: 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
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
Part A: Number of Participants With a Secondary Case Definition of COVID-19 Starting 14 Days After Second Dose
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
Parts A and B: Number of Participants Who Died Due to a Cause Directly Attributed to a Complication of COVID-19 Starting 14 Days After Second Dose
From Day 43 (14 days after second dose) up to approximately 8 months for Part A and from PDV/unblinding (at 4 months) to up to 8 months for Part B
- +10 more secondary outcomes
Study Arms (2)
mRNA-1273
EXPERIMENTALPart 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.
Placebo
PLACEBO COMPARATORPart A only: Participants will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29, if the participant chooses.
Interventions
Eligibility Criteria
You may qualify if:
- (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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (100)
Ascension St. Vincent Birmingham
Birmingham, Alabama, 35205, United States
Synexus Clinical Research US, Inc. - Birmingham
Birmingham, Alabama, 35211, United States
Hope Research Institute
Chandler, Arizona, 85224, United States
Synexus Clinical Research US, Inc. - Phoenix West
Glendale, Arizona, 85306, United States
Hope Research Institute
Peoria, Arizona, 85018, United States
Hope Research Institute
Phoenix, Arizona, 85018, United States
Quality of Life Medical and Research Center
Tucson, Arizona, 85712, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Advanced Clinical Research - Rancho Paseo
Banning, California, 92220, United States
University of California San Diego
La Jolla, California, 92093, United States
eStudySite - La Mesa
La Mesa, California, 91942, United States
UCLA Vine Street Clinic CRS
Los Angeles, California, 90038, United States
VA Greater Los Angeles Healthcare (veterans only)
Los Angeles, California, 90073, United States
Paradigm Clinical Research Institute Inc
Redding, California, 96001, United States
Benchmark Research - Sacramento
Sacramento, California, 95864, United States
Medical Center For Clinical Research - M3 Wake Research
San Diego, California, 92108, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Lynn Institute of The Rockies
Colorado Springs, Colorado, 80918, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Accel Research Site
DeLand, Florida, 32720, United States
Research Centers of America
Hollywood, Florida, 33024, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Synexus - Optimal Research - Melbourne
Melbourne, Florida, 32934, United States
Suncoast Research Group
Miami, Florida, 33135, United States
University of Miami
Miami, Florida, 33136, United States
Synexus Clinical Research US, Inc. - Orlando
Orlando, Florida, 32806, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Hope Clinic of The Emory Vaccine Center
Decatur, Georgia, 30030, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois, 60602, United States
UIC Project WISH CRS
Chicago, Illinois, 60612, United States
University of Chicago-Hospital
Chicago, Illinois, 60637, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Alliance for Multispecialty Research
Newton, Kansas, 67114, United States
Alliance for Multispecialty Research- East Wichita
Wichita, Kansas, 67207, United States
Meridian Clinical Research
Baton Rouge, Louisiana, 70808, United States
Benchmark Research - Metairie
Metairie, Louisiana, 70006, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Synexus - Optimal Research - Rockville
Rockville, Maryland, 20850, United States
Meridian Clinical Research
Rockville, Maryland, 20854, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
MediSync Clinical Research Hattiesburg Clinic
Petal, Mississippi, 39465, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Meridian Clinical Research
Grand Island, Nebraska, 68803, United States
Meridian Clinical Research
Norfolk, Nebraska, 68701, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
New Jersey Medical School
Newark, New Jersey, 07103, United States
Meridian Clinical Research
Binghamton, New York, 13901, United States
Weill Cornell Chelsea - (CRS)
New York, New York, 10010, United States
Weill Cornell Medical College
New York, New York, 10065, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Tryon Medical Partners
Charlotte, North Carolina, 28210, United States
Carolina Institute for Clinical Research - M3 Wake Research
Fayetteville, North Carolina, 28304, United States
M3 Wake Research, Inc - M3 Wake
Raleigh, North Carolina, 27612, United States
Trial Management Associates
Wilmington, North Carolina, 28403, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati, Ohio, 45236, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Cincinnati CRS
Cincinnati, Ohio, 45267, United States
Rapid Medical Research Inc
Cleveland, Ohio, 44122, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Crisor
Medford, Oregon, 97504, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UPMC University Center
Pittsburgh, Pennsylvania, 15213, United States
Keystone VitaLink Research
Anderson, South Carolina, 29621, United States
Keystone VitaLink Research - Greenville
Greenville, South Carolina, 29615, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Keystone VitaLink Research - Spartanburg
Spartanburg, South Carolina, 29303, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049, United States
WR-ClinSearch
Chattanooga, Tennessee, 37421, United States
Alliance for Multispecialty Research
Knoxville, Tennessee, 39720, United States
Vanderbilt University Medical Center, Medical Arts Building
Nashville, Tennessee, 37232, United States
Vanderbilt University Medical Center, Medical Center North
Nashville, Tennessee, 37232, United States
Benchmark Research - Austin
Austin, Texas, 78705, United States
Synexus - Optimal Research - Austin
Austin, Texas, 78705, United States
Tekton Research
Austin, Texas, 78745, United States
Advanced Clinical Research - Be Well MD
Cedar Park, Texas, 78613, United States
Global Medical Research - M3 Wake Research
Dallas, Texas, 75224, United States
Synexus Clinical Research US, Inc. - Dallas
Dallas, Texas, 75234, United States
Benchmark Research - Fort Worth
Fort Worth, Texas, 76135, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
DM Clinical Research - Texas Center For Drug Development
Houston, Texas, 77081, United States
Laguna Clinical Research
Laredo, Texas, 78041, United States
Centex Studies
McAllen, Texas, 78504, United States
Benchmark Research - San Angelo
San Angelo, Texas, 76904, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, 78229, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Synexus Clinical Research US, Inc. - Salt Lake City
Murray, Utah, 84123, United States
Foothill Family Clinic - North
Salt Lake City, Utah, 84109, United States
Foothill Family Clinic-South Clinic
Salt Lake City, Utah, 84121, United States
Kaiser Permanente - Seattle
Seattle, Washington, 98101, United States
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PMID: 34551225DERIVEDGilbert PB, Montefiori DC, McDermott A, Fong Y, Benkeser D, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Castellino F, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi N, Huynh C, Miller J, El Sahly HM, Baden LR, Baron M, De La Cruz L, Gay C, Kalams S, Kelley CF, Kutner M, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Carpp LN, Pajon R, Follmann D, Donis RO, Koup RA. Immune Correlates Analysis of the mRNA-1273 COVID-19 Vaccine Efficacy Trial. medRxiv [Preprint]. 2021 Aug 15:2021.08.09.21261290. doi: 10.1101/2021.08.09.21261290.
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Moderna Clinical Trials Support Center
- Organization
- ModernaTX, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Part A is observer-blind. Part B is open-label; participants can request to be unblinded by scheduling a Participant Decision clinic visit. Part C offers participants the option to receive a booster dose for those participants who received at least one dose of mRNA-1273 in the study.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2020
First Posted
July 14, 2020
Study Start
July 27, 2020
Primary Completion
December 29, 2022
Study Completion
December 29, 2022
Last Updated
March 21, 2024
Results First Posted
March 21, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share