<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04470427</url>
  </required_header>
  <id_info>
    <org_study_id>mRNA-1273-P301</org_study_id>
    <secondary_id>75A50120C00034</secondary_id>
    <nct_id>NCT04470427</nct_id>
  </id_info>
  <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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ModernaTX, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biomedical Advanced Research and Development Authority</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>ModernaTX, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from&#xD;
      Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed&#xD;
      to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent&#xD;
      COVID-19 for up to 2 years after the second dose of mRNA-1273.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 3-part Phase 3 study, with Part A (Blinded Phase), Part B (Open-label Observational&#xD;
      Phase), and Part C (Booster Dose Phase). Participants in Part A are blinded to their&#xD;
      treatment assignment, with participants receiving either mRNA-1273 vaccine or placebo. Part B&#xD;
      of the study is designed to offer participants to be unblinded so that participants who&#xD;
      received placebo in Part A can request 2 doses of open-label mRNA-1273 vaccine. Additionally,&#xD;
      participants who choose to be unblinded and were only able to receive 1 dose of mRNA-1273 due&#xD;
      to administrative reasons, can choose to receive the second dose of mRNA-1273 during Part B.&#xD;
      In Part C, a booster dose will be provided for all eligible participants who choose to&#xD;
      receive one.&#xD;
&#xD;
      Please access www.modernatx.com/cove-study for additional information, such as Study&#xD;
      Overview, Participation, and Site Locations along with contact numbers for each location for&#xD;
      the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">December 29, 2022</completion_date>
  <primary_completion_date type="Actual">December 29, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of mRNA-1273</measure>
    <time_frame>Part A only: Day 43 (14 days after second dose) up to Day 759 (2 years after second dose)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal</measure>
    <time_frame>Up to Day 759 (2 years after second dose)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)</measure>
    <time_frame>Part A only: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Number of Participants with Unsolicited AEs</measure>
    <time_frame>Part A and C only: Up to Day 57 (28 days after each dose)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Number of Participants with Serious AEs (SAEs)</measure>
    <time_frame>Up to Day 759 (2 years after second dose)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of mRNA-1273 or Placebo</measure>
    <time_frame>Day 43 (14 days after second dose) up to Day 759 (2 years after second dose)</time_frame>
    <description>Clinical signs indicative of severe COVID-19 as predefined for the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Day 43 (14 days after second dose) up to Day 759 (2 years after second dose)</time_frame>
    <description>Clinical signs indicative of COVID-19 and SARS-CoV-2 Infection as predefined for the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with a Secondary Case Definition of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo</measure>
    <time_frame>Day 43 (14 days after second dose) up to Day 759 (2 years after second dose)</time_frame>
    <description>Clinical signs indicative of secondary case definition of COVID-19 as predefined for the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of mRNA-1273 or Placebo</measure>
    <time_frame>Day 43 (14 days after first dose of the Blinded Phase) up to Day 759 (2 years after second dose)</time_frame>
    <description>Clinical signs indicative of COVID-19 as predefined for the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Day 43 (14 days after second dose) up to Day 759 (2 years after second dose)</time_frame>
    <description>Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Day 43 (14 days after second dose) up to Day 759 (2 years after second dose)</time_frame>
    <description>Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)</measure>
    <time_frame>Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb</measure>
    <time_frame>Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantified Levels or GMT of S Protein-Specific Binding Antibody (bAb)</measure>
    <time_frame>Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMFR of S Protein Specific bAb</measure>
    <time_frame>Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Seroresponse Against SARS-CoV-2 (Part C Only)</measure>
    <time_frame>Post-booster dose Day 29</time_frame>
    <description>Seroresponse is defined as a titer change from baseline (predose 1 in primary series) below the lower limit of quantitation (LLOQ) to ≥ 4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30000</enrollment>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>mRNA-1273</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A (Blinded): Participants will receive 1 intramuscular (IM) injection of 100 microgram (μg) mRNA-1273 on Day 1 and on Day 29.&#xD;
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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>mRNA-1273</intervention_name>
    <description>Sterile liquid for injection</description>
    <arm_group_label>mRNA-1273</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.9% sodium chloride (normal saline) injection</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>mRNA-1273</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (Part A only) Participants who are at high risk of SARS-CoV-2 infection, defined as&#xD;
             adults whose locations or circumstances put them at appreciable risk of exposure to&#xD;
             SARS-CoV-2 and COVID-19.&#xD;
&#xD;
          -  Understands and agrees to comply with the study procedures and provides written&#xD;
             informed consent.&#xD;
&#xD;
          -  Able to comply with study procedures based on the assessment of the Investigator.&#xD;
&#xD;
          -  Female participants of non-childbearing potential may be enrolled in the study.&#xD;
             Non-childbearing potential is defined as surgically sterile (history of bilateral&#xD;
             tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as&#xD;
             amenorrhea for ≥12 consecutive months prior to Screening without an alternative&#xD;
             medical cause). A follicle-stimulating hormone (FSH) level may be measured at the&#xD;
             discretion of the Investigator to confirm postmenopausal status.&#xD;
&#xD;
          -  Female participants of childbearing potential may be enrolled in the study if the&#xD;
             participant fulfills all the following criteria:&#xD;
&#xD;
               -  Has a negative pregnancy test at Screening and on the day of the first dose (Day&#xD;
                  1, open-label Day 1, and booster dose Day 1).&#xD;
&#xD;
               -  Has practiced adequate contraception or has abstained from all activities that&#xD;
                  could result in pregnancy for at least 28 days prior to the first dose (Day 1).&#xD;
&#xD;
               -  Has agreed to continue adequate contraception through 3 months following the last&#xD;
                  dose (Day 29, open-label Day 29, and booster dose Day 1).&#xD;
&#xD;
               -  Is not currently breastfeeding.&#xD;
&#xD;
          -  Healthy adults or adults with pre-existing medical conditions who are in stable&#xD;
             condition. A stable medical condition is defined as disease not requiring significant&#xD;
             change in therapy or hospitalization for worsening disease during the 3 months before&#xD;
             enrollment.&#xD;
&#xD;
          -  (Part C Only) Is currently enrolled in Part B of the current study (mRNA-1273-P301).&#xD;
&#xD;
          -  (Part C Only) Has received at least 1 dose of mRNA-1273 in the current study&#xD;
             (mRNA-1273-P301).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is acutely ill or febrile 72 hours prior to or at Screening or dosing (Part B and Part&#xD;
             C). Fever is defined as a body temperature ≥38.0°Celsius/100.4°Fahrenheit.&#xD;
             Participants meeting this criterion may be rescheduled within the relevant window&#xD;
             periods. Afebrile participants with minor illnesses can be enrolled/dosed at the&#xD;
             discretion of the Investigator.&#xD;
&#xD;
          -  Is pregnant or breastfeeding.&#xD;
&#xD;
          -  (Part A Only) Known history of SARS-CoV-2 infection.&#xD;
&#xD;
          -  Prior (Part A) or concurrent (Part B and Part C) administration of non-study&#xD;
             coronavirus (SARS-CoV, Middle East Respiratory Syndrome [MERS]-CoV) vaccine or&#xD;
             current/planned simultaneous participation in another interventional study to prevent&#xD;
             or treat COVID-19.&#xD;
&#xD;
          -  (Part A Only) Demonstrated inability to comply with the study procedures.&#xD;
&#xD;
          -  An immediate family member or household member of this study's personnel.&#xD;
&#xD;
          -  Known or suspected allergy or history of anaphylaxis, urticaria, or other significant&#xD;
             adverse reaction to the vaccine or its excipients.&#xD;
&#xD;
          -  Bleeding disorder considered a contraindication to intramuscular injection or&#xD;
             phlebotomy.&#xD;
&#xD;
          -  Has received or plans to receive a vaccine within 28 days prior to the first dose (Day&#xD;
             1) or plans to receive a non-study vaccine within 28 days prior to or after any dose&#xD;
             of investigational product (IP) (except for seasonal influenza vaccine).&#xD;
&#xD;
          -  (Part A only) Has participated in an interventional clinical study within 28 days&#xD;
             prior to the day of enrollment.&#xD;
&#xD;
          -  Immunosuppressive or immunodeficient state, including human immunodeficiency virus&#xD;
             (HIV) infection, asplenia, and recurrent severe infections.&#xD;
&#xD;
          -  Has received systemic immunosuppressants or immune-modifying drugs for &gt;14 days in&#xD;
             total within 6 months prior to IP dose administration (for corticosteroids ≥20&#xD;
             milligram (mg)/day of prednisone equivalent).&#xD;
&#xD;
          -  Has received systemic immunoglobulins or blood products within 3 months prior to the&#xD;
             day of IP dose administration.&#xD;
&#xD;
          -  Has donated ≥450 milliliters (mL) of blood products within 28 days prior to IP dose&#xD;
             administration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ascension St. Vincent Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Research Institute</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Phoenix West</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Research Institute</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Research Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality of Life Medical and Research Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health Center for Clinical Research</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research - Rancho Paseo</name>
      <address>
        <city>Banning</city>
        <state>California</state>
        <zip>92220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>eStudySite - La Mesa</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Vine Street Clinic CRS</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Greater Los Angeles Healthcare (veterans only)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paradigm Clinical Research Institute Inc</name>
      <address>
        <city>Redding</city>
        <state>California</state>
        <zip>96001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research - Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center For Clinical Research - M3 Wake Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Institute of The Rockies</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80918</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Site</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centers of America</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacksonville Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Optimal Research - Melbourne</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32934</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Research Group</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Beach Research Center</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grady Health System</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Clinic of The Emory Vaccine Center</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Atlanta</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UIC Project WISH CRS</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago-Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johnson County Clin-Trials</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Multispecialty Research</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Multispecialty Research- East Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research - Metairie</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Optimal Research - Rockville</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSync Clinical Research Hattiesburg Clinic</name>
      <address>
        <city>Petal</city>
        <state>Mississippi</state>
        <zip>39465</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sundance Clinical Research</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Grand Island</city>
        <state>Nebraska</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AB Clinical Trials</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Jersey Medical School</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Chelsea - (CRS)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tryon Medical Partners</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Institute for Clinical Research - M3 Wake Research</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M3 Wake Research, Inc - M3 Wake</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trial Management Associates</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizons Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati CRS</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid Medical Research Inc</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Health Science Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crisor</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC University Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keystone VitaLink Research</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keystone VitaLink Research - Greenville</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keystone VitaLink Research - Spartanburg</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WR-ClinSearch</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Multispecialty Research</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>39720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center, Medical Arts Building</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center, Medical Center North</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research - Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Optimal Research - Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research - Be Well MD</name>
      <address>
        <city>Cedar Park</city>
        <state>Texas</state>
        <zip>78613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Medical Research - M3 Wake Research</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research - Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch at Galveston</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DM Clinical Research - Texas Center For Drug Development</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laguna Clinical Research</name>
      <address>
        <city>Laredo</city>
        <state>Texas</state>
        <zip>78041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research - San Angelo</name>
      <address>
        <city>San Angelo</city>
        <state>Texas</state>
        <zip>76904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DM Clinical Research</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Salt Lake City</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothill Family Clinic - North</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothill Family Clinic-South Clinic</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - Seattle</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.modernatx.com/cove-study</url>
    <description>Click here to access the website, www.modernatx.com/cove-study, for additional information for the study, such as Study Overview, Participation, and Site Locations, along with contact numbers for each location for the study.</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mRNA-1273</keyword>
  <keyword>mRNA-1273 vaccine</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>SARS-CoV-2 Vaccine</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>Virus Diseases</keyword>
  <keyword>Messenger RNA</keyword>
  <keyword>COVID-19</keyword>
  <keyword>COVID-19 Vaccine</keyword>
  <keyword>Moderna</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04470427
org study id: mRNA-1273-P301
secondary id: 75A50120C00034
nct id: NCT04470427
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: 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.
measure: Efficacy: Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of mRNA-1273
time frame: Part A only: Day 43 (14 days after second dose) up to Day 759 (2 years after second dose)
measure: Safety: 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)
measure: Safety: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
time frame: Part A only: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose)
measure: Safety: Number of Participants with Unsolicited AEs
time frame: Part A and C only: Up to Day 57 (28 days after each dose)
measure: Safety: Number of Participants with Serious AEs (SAEs)
time frame: Up to Day 759 (2 years after second dose)
measure: Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of mRNA-1273 or Placebo
time frame: Day 43 (14 days after second dose) up to Day 759 (2 years after second dose)
description: Clinical signs indicative of severe COVID-19 as predefined for the study.
measure: 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 43 (14 days after second dose) up to Day 759 (2 years after second dose)
description: Clinical signs indicative of COVID-19 and SARS-CoV-2 Infection as predefined for the study.
measure: 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 43 (14 days after second dose) up to Day 759 (2 years after second dose)
description: Clinical signs indicative of secondary case definition of COVID-19 as predefined for the study.
measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of mRNA-1273 or Placebo
time frame: Day 43 (14 days after first dose of the Blinded Phase) up to Day 759 (2 years after second dose)
description: Clinical signs indicative of COVID-19 as predefined for the study.
measure: 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 43 (14 days after second dose) up to Day 759 (2 years after second dose)
description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.
measure: 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 43 (14 days after second dose) up to Day 759 (2 years after second dose)
description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.
measure: 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
measure: 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
measure: 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
measure: GMFR of S Protein Specific bAb
time frame: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759
measure: Number of Participants With Seroresponse Against SARS-CoV-2 (Part C Only)
time frame: Post-booster dose Day 29
description: Seroresponse is defined as a titer change from baseline (predose 1 in primary series) below the lower limit of quantitation (LLOQ) to ≥ 4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ.
arm group label: mRNA-1273
arm group type: Experimental
description: 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.
arm group label: Placebo
arm group type: Placebo Comparator
description: 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.
intervention type: Biological
intervention name: mRNA-1273
description: Sterile liquid for injection
arm group label: mRNA-1273
intervention type: Biological
intervention name: Placebo
description: 0.9% sodium chloride (normal saline) injection
arm group label: Placebo
arm group label: mRNA-1273
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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country: United States
url: https://www.modernatx.com/cove-study
description: Click here to access the website, www.modernatx.com/cove-study, for additional information for the study, such as Study Overview, Participation, and Site Locations, along with contact numbers for each location for the study.
responsible party type: Sponsor
sharing ipd: No