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AzTrials

SARS-CoV-2Phase 3NCT04470427

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 study testing mRNA-1273 in people with SARS-CoV-2, run by ModernaTX, Inc. at 100 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2
What is being tested?
mRNA-1273
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30,415 participants
Where
100 sitesUnited States
Study dates
27 Jul 2020to 29 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • (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).
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

100 sites in 1 country.

100 sites in 1 country

United States100 sites

  • Keystone VitaLink Research

    Anderson, South Carolina, 29621

  • Grady Health System

    Atlanta, Georgia, 30303

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Benchmark Research - Austin

    Austin, Texas, 78705

  • Synexus - Optimal Research - Austin

    Austin, Texas, 78705

  • Tekton Research

    Austin, Texas, 78745

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Advanced Clinical Research - Rancho Paseo

    Banning, California, 92220

  • Meridian Clinical Research

    Baton Rouge, Louisiana, 70808

  • Meridian Clinical Research

    Binghamton, New York, 13901

  • Ascension St. Vincent Birmingham

    Birmingham, Alabama, 35205

  • Synexus Clinical Research US, Inc. - Birmingham

    Birmingham, Alabama, 35211

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Advanced Clinical Research - Be Well MD

    Cedar Park, Texas, 78613

  • Hope Research Institute

    Chandler, Arizona, 85224

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Tryon Medical Partners

    Charlotte, North Carolina, 28210

  • WR-ClinSearch

    Chattanooga, Tennessee, 37421

  • Synexus Clinical Research US, Inc. - Chicago

    Chicago, Illinois, 60602

  • UIC Project WISH CRS

    Chicago, Illinois, 60612

  • University of Chicago-Hospital

    Chicago, Illinois, 60637

  • Synexus Clinical Research US, Inc. - Cincinnati

    Cincinnati, Ohio, 45236

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Cincinnati CRS

    Cincinnati, Ohio, 45267

  • Rapid Medical Research Inc

    Cleveland, Ohio, 44122

  • Lynn Institute of The Rockies

    Colorado Springs, Colorado, 80918

  • Meridian Clinical Research

    Dakota Dunes, South Dakota, 57049

  • Global Medical Research - M3 Wake Research

    Dallas, Texas, 75224

  • Synexus Clinical Research US, Inc. - Dallas

    Dallas, Texas, 75234

  • Hope Clinic of The Emory Vaccine Center

    Decatur, Georgia, 30030

  • Accel Research Site

    DeLand, Florida, 32720

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Carolina Institute for Clinical Research - M3 Wake Research

    Fayetteville, North Carolina, 28304

  • Benchmark Research - Fort Worth

    Fort Worth, Texas, 76135

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555

  • Synexus Clinical Research US, Inc. - Phoenix West

    Glendale, Arizona, 85306

  • Meridian Clinical Research

    Grand Island, Nebraska, 68803

  • Keystone VitaLink Research - Greenville

    Greenville, South Carolina, 29615

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Research Centers of America

    Hollywood, Florida, 33024

  • Baylor College of Medicine

    Houston, Texas, 77030

  • DM Clinical Research - Texas Center For Drug Development

    Houston, Texas, 77081

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Alliance for Multispecialty Research

    Knoxville, Tennessee, 39720

  • University of California San Diego

    La Jolla, California, 92093

  • eStudySite - La Mesa

    La Mesa, California, 91942

  • Laguna Clinical Research

    Laredo, Texas, 78041

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89104

  • AB Clinical Trials

    Las Vegas, Nevada, 89119

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • UCLA Vine Street Clinic CRS

    Los Angeles, California, 90038

  • VA Greater Los Angeles Healthcare (veterans only)

    Los Angeles, California, 90073

  • Centex Studies

    McAllen, Texas, 78504

  • Crisor

    Medford, Oregon, 97504

  • Synexus - Optimal Research - Melbourne

    Melbourne, Florida, 32934

  • Benchmark Research - Metairie

    Metairie, Louisiana, 70006

  • Suncoast Research Group

    Miami, Florida, 33135

  • University of Miami

    Miami, Florida, 33136

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Synexus Clinical Research US, Inc. - Salt Lake City

    Murray, Utah, 84123

  • Vanderbilt University Medical Center, Medical Arts Building

    Nashville, Tennessee, 37232

  • Vanderbilt University Medical Center, Medical Center North

    Nashville, Tennessee, 37232

  • Weill Cornell Chelsea - (CRS)

    New York, New York, 10010

  • Weill Cornell Medical College

    New York, New York, 10065

  • New Jersey Medical School

    Newark, New Jersey, 07103

  • Alliance for Multispecialty Research

    Newton, Kansas, 67114

  • Meridian Clinical Research

    Norfolk, Nebraska, 68701

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Meridian Clinical Research

    Omaha, Nebraska, 68134

  • Synexus Clinical Research US, Inc. - Orlando

    Orlando, Florida, 32806

  • Hope Research Institute

    Peoria, Arizona, 85018

  • MediSync Clinical Research Hattiesburg Clinic

    Petal, Mississippi, 39465

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Hope Research Institute

    Phoenix, Arizona, 85018

  • UPMC University Center

    Pittsburgh, Pennsylvania, 15213

  • M3 Wake Research, Inc - M3 Wake

    Raleigh, North Carolina, 27612

  • Paradigm Clinical Research Institute Inc

    Redding, California, 96001

  • Synexus - Optimal Research - Rockville

    Rockville, Maryland, 20850

  • Meridian Clinical Research

    Rockville, Maryland, 20854

  • Benchmark Research - Sacramento

    Sacramento, California, 95864

  • Foothill Family Clinic - North

    Salt Lake City, Utah, 84109

  • Foothill Family Clinic-South Clinic

    Salt Lake City, Utah, 84121

  • Benchmark Research - San Angelo

    San Angelo, Texas, 76904

  • Clinical Trials of Texas, Inc

    San Antonio, Texas, 78229

  • Medical Center For Clinical Research - M3 Wake Research

    San Diego, California, 92108

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Kaiser Permanente - Seattle

    Seattle, Washington, 98101

  • Keystone VitaLink Research - Spartanburg

    Spartanburg, South Carolina, 29303

  • Saint Louis University

    St Louis, Missouri, 63104

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • DM Clinical Research

    Tomball, Texas, 77375

  • Quality of Life Medical and Research Center

    Tucson, Arizona, 85712

  • George Washington University

    Washington D.C., District of Columbia, 20037

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Alliance for Multispecialty Research- East Wichita

    Wichita, Kansas, 67207

  • Trial Management Associates

    Wilmington, North Carolina, 28403

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Read the 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
Being tested
mRNA-1273, Placebo
Keywords
mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Medical subject headings
Coronavirus Infections, Virus Diseases, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1273Biological

    Sterile liquid for injection

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

Study groups in NCT04470427
Study groupRoleWhat they receive
mRNA-1273ExperimentalPart 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.
Receives: Biological: mRNA-1273; Biological: Placebo
PlaceboPlacebo 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.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose

  2. 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.

    Measured: up to Day 7 (7 days after first dose)

  3. 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

    Measured: Day 29 to Day 35 (from second dose to 7 days after second dose)

  4. 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.

    Measured: Day 1 (after dosing) through end of study (up to Day 759)

  5. 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.

    Measured: Day 1 (after dosing) through end of study (up to Day 759)

Secondary outcomes (15)

  1. Part A: Number of Participants With Unsolicited AEs up to 28 Days After Any Injection Dose

    Unsolicited AE was any AE reported by the participant that was not specified as an AR or was specified as a solicited AR in the protocol but started outside the protocol-defined, post-injection period for reporting solicited ARs. Unsolicited AEs were collected for the 28 days after any injection.

    An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section.

    Measured: Up to 28 days after any dose

  2. Parts A and B: Number of Participants With a First Occurrence of Severe COVID-19 Starting 14 Days After Second Dose

    COVID-19 cases were defined as participants meeting clinical criteria based on symptoms for COVID-19 and reverse transcriptase polymerase chain reaction (RT-PCR) detection of SARS-CoV-2 from samples collected within 72 hours of the participant reporting symptoms meeting the definition of COVID-19.

    An adjudication committee reviewed potential cases to determine if the criteria for COVID-19 were met.

    Clinical signs indicative of severe COVID-19 systemic illness included any of the following: respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, oxygen saturation (SpO2) ≤93% on room air at sea level, or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <300 millimeter of mercury (mm Hg), or respiratory failure or acute respiratory distress syndrome (ARDS), evidence of shock, or significant acute renal, hepatic, or neurologic dysfunction, or admission to an intensive care unit or death.

    Measured: 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

  3. 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

    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.

    SARS-CoV-2 infection was defined by seroconversion due to infection measured by binding antibody (bAb) levels against SARS-CoV-2 nucleocapsid or by positive RT-PCR at predefined timepoints. Seroconversion was defined by the participant's serostatus at baseline.

    Measured: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose

  4. Part A: Number of Participants With a Secondary Case Definition of COVID-19 Starting 14 Days After Second Dose

    Secondary case definition of COVID-19 was defined as the presence of at least 1 of the following systemic symptoms: fever (temperature

    ≥38ºC), or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or rhinorrhea, nausea or vomiting, or diarrhea and a positive nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) for SARS-CoV-2 by RT-PCR.

    Measured: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose

  5. 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

    Measured: 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

  6. Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After First 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.

    Measured: From 14 days after first dose up to approximately 8 months

  7. Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose Regardless of Evidence of Prior SARS-CoV-2 Infection

    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.

    Measured: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose

  8. Part A: 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

    SARS-CoV-2 infection was defined by seroconversion due to infection measured by binding antibody (bAb) levels against SARS-CoV-2 nucleocapsid or by positive RT-PCR at predefined timepoints. Seroconversion was defined by the participant's serostatus at baseline.

    Measured: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose

  9. Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)

    GMT (50% inhibitory dose [ID50], 80% inhibitory dose [ID80]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported.

    95% CI was based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation.

    Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1.

    Measured: Day 1, Day 29, Day 57

  10. Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb

    The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants.

    95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. GMFR for ID50 and ID80 neutralizing antibodies against SARS-CoV-2 S-protein, as measured by pseudovirus neutralizing antibody is presented. Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1

    Measured: Day 29, Day 57

  11. Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2

    Seroresponse to pseudovirus neutralizing antibody ID50 titer at a participant level is defined as a change from below the LLOQ to equal or above the LLOQ, or at least a 3.3-fold rise if baseline is equal to or above the LLOQ. Seroresponse to pseudovirus neutralizing antibody ID80 titer at a participant level is defined as a change from below the LLOQ to equal or above the LLOQ, or at least a 2.3-fold rise if baseline is equal to or above the LLOQ.

    Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1.

    Measured: Day 29, Day 57

  12. Part C: GMT of SARS-CoV-2 Specific nAb Measured by Pseudovirus (VAC62)

    95% CI is calculated based on the t-distribution of the log-transformed values for GM value, then back transformed to the original scale for presentation.

    Measured: Pre-booster (Baseline), post-booster Day 29 and post-booster Day 181

  13. Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 Measured by Pseudovirus (VAC62)

    Pseudovirus neutralizing antibody (VAC62) from pre-booster is presented. Seroresponse at a participant level is defined as a change from below the LLOQ to >= 4 x LLOQ, or at least a 4-fold rise if pre-booster is equal to or above the LLOQ.

    Measured: Post-booster Day 29 and post-booster Day 181

  14. Part C: Geometric Mean Concentration (GMC) of SARS-CoV-2 Specific nAb After BD Compared to After Second Dose in Part A Measured by Pseudovirus (VAC62)

    95% CI is calculated based on the t-distribution of the log-transformed values for GMC, then back transformed to the original scale for presentation.

    Measured: Part C BD Day 29 and Part A Day 57

  15. Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 After BD Compared to After Second Dose in Part A

    Pseudovirus neutralizing antibody (VAC62) are presented. Seroresponse at a participant level is defined as a change from below the LLOQ to equal or above 4 x LLOQ, or at least a4-fold rise if baseline (Pre- Dose 1) is equal to or above the LLOQ.

    Measured: Part C BD Day 29 and Part A Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start27 Jul 2020
  3. Primary completion29 Dec 2022
  4. Study completion29 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30,415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04470427
Sponsor's protocol ID
mRNA-1273-P301
Other IDs
75A50120C00034
Status last verified
Mar 2024
First submitted
11 Jul 2020
Last updated
21 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kaplonek P, Bertera H, Lee DW, Cizmeci D, Yu WH, Wu K, Chalkias S, Wahid R, Edwards D, Alter G, Henry C. IgG4 Neutralization and Sustained Total IgG Fc-Effector Functions Following Repeated SARS-CoV-2 Vaccination with mRNA-1273. Infect Dis Ther. 2026 Mar;15(3):859-874. doi: 10.1007/s40121-026-01303-w. Epub 2026 Feb 1.

    PubMed 41622397

  • Kenny A, van der Laan L, Gilbert P, Carone M. Inference on Controlled Effects for Assessing Immune Correlates of Protection Based on a Cox Model. Stat Med. 2025 Dec;44(28-30):e70347. doi: 10.1002/sim.70347.

    PubMed 41369204

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mRNA-1273 in people with SARS-CoV-2, run by ModernaTX, Inc. at 100 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose (time frame: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04470427, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.

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