<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/NCT04498247</url>
  </required_header>
  <id_info>
    <org_study_id>V591-001</org_study_id>
    <secondary_id>2020-003493-46</secondary_id>
    <secondary_id>V591-001</secondary_id>
    <nct_id>NCT04498247</nct_id>
  </id_info>
  <brief_title>A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001)</brief_title>
  <official_title>A Phase 1/Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety, Tolerability and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Younger and Older Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</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 primary objective of this early Phase 1/2 study is to identify the V591 dose that&#xD;
      achieves the target immune response in humans based on preclinical or early clinical data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was terminated and modifications to the dosing regimens and clinical/laboratory&#xD;
      procedures were implemented for trial discontinuation according to Protocol Amendment 04. Per&#xD;
      protocol, certain panels were never enrolled and/or the second dose of study intervention was&#xD;
      not administered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated based on an interim assessment of immunogenicity&#xD;
  </why_stopped>
  <start_date type="Actual">August 27, 2020</start_date>
  <completion_date type="Actual">March 5, 2021</completion_date>
  <primary_completion_date type="Actual">March 5, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One Solicited Injection Site Adverse Event (AE) After Any Study Intervention</measure>
    <time_frame>Up to 5 days after any study intervention</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection site AEs of pain/tenderness, swelling, and redness/erythema were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One Solicited Systemic AE After Any Study Intervention</measure>
    <time_frame>Up to 14 days after any study intervention</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Systemic AEs of fever, muscle pain, joint pain, headache, fatigue, rash, or nausea were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One Unsolicited Adverse Event After Any Study Intervention</measure>
    <time_frame>Up to 28 days after any study intervention</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All unsolicited AEs were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least 1 Serious Adverse Event</measure>
    <time_frame>Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)</time_frame>
    <description>An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event</measure>
    <time_frame>Up to 57 days</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least 1 Medically Attended Adverse Event (MAAE)</measure>
    <time_frame>Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)</time_frame>
    <description>A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)</measure>
    <time_frame>Days 1, 15, 29, 57, 71, and 85</time_frame>
    <description>Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a constrained longitudinal data analysis (cLDA) method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)</measure>
    <time_frame>Days 1, 15, 29, 57, 71, and 85</time_frame>
    <description>Serum samples were collected and the concentrations of total anti-spike IgG antibodies were assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA</measure>
    <time_frame>Days 1, 15, 29, 57, 71, and 85</time_frame>
    <description>Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA</measure>
    <time_frame>Days 1, 15, 29, 57, 71, and 85</time_frame>
    <description>Serum samples were collected and the total anti-spike IgG antibodies assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">263</enrollment>
  <condition>Coronavirus Disease (COVID-19)</condition>
  <arm_group>
    <arm_group_label>Panel A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this 18 to 55 year old sentinel cohort will receive 2 doses (Day 1 and Day 57) of 1x10^5 50% tissue culture infectious dose (TCID50) V591 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this 18 to 55 year old sentinel cohort will receive 2 doses (Days 1 and 57) of 1x10^6 TCID50 V591 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panels C, G</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this 18 to 55 year old cohort (Panel C) or &gt;55 year old cohort (Panel G) will receive 1 dose of 1x10^5 TCID50 V591 or placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panels D, H</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this 18 to 55 year old cohort (Panel D) or &gt;55 year old cohort (Panel H) will receive 1 dose of 1x10^6 TCID50 V591 or placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this 18 to 55 year old cohort will receive 1 dose of 1x10^7 V591 or placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this 18 to 55 year old cohort will receive 2 doses (Days 1 and 169) of V591 or placebo. Day 1 will be 1x10^4 TCID50 V591 or placebo and Day 169 will be 1x10^5 TCID50 V591 or placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this &gt;55 year old cohort will receive 2 doses (Days 1 and 57) of 1x10^5 TCID50 V591 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel J</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this &gt;55 year old cohort will receive 2 doses (Days 1 and 57) of 1x10^6 TCID50 V591 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel K</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this &gt;55 year old cohort will receive 2 doses (Days 1 and 169) of 1x10^5 TCID50 V591 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel L</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this &gt;55 year old cohort will receive 2 doses (Days 1 and 169) of 1x10^6 TCID50 V591 or placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>V591</intervention_name>
    <description>1 or 2 ascending doses of V591 will be administered via intramuscular (IM) injection.</description>
    <arm_group_label>Panel A</arm_group_label>
    <arm_group_label>Panel B</arm_group_label>
    <arm_group_label>Panel E</arm_group_label>
    <arm_group_label>Panel F</arm_group_label>
    <arm_group_label>Panel I</arm_group_label>
    <arm_group_label>Panel J</arm_group_label>
    <arm_group_label>Panel K</arm_group_label>
    <arm_group_label>Panel L</arm_group_label>
    <arm_group_label>Panels C, G</arm_group_label>
    <arm_group_label>Panels D, H</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (0.9% sodium chloride) administered via IM injection.</description>
    <arm_group_label>Panel A</arm_group_label>
    <arm_group_label>Panel B</arm_group_label>
    <arm_group_label>Panel E</arm_group_label>
    <arm_group_label>Panel F</arm_group_label>
    <arm_group_label>Panel I</arm_group_label>
    <arm_group_label>Panel J</arm_group_label>
    <arm_group_label>Panel K</arm_group_label>
    <arm_group_label>Panel L</arm_group_label>
    <arm_group_label>Panels C, G</arm_group_label>
    <arm_group_label>Panels D, H</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is in overall good health based on medical history, physical examination,&#xD;
             electrocardiogram (ECG) and vital sign (VS) measurements performed prior to&#xD;
             randomization.&#xD;
&#xD;
          -  Is in overall good health based on laboratory safety tests obtained at the screening&#xD;
             visit.&#xD;
&#xD;
          -  Has a body mass index (BMI) &lt;30 kg/m2 inclusive. On this basis a rounded BMI of 29.9&#xD;
             is acceptable to satisfy the inclusion criteria. BMI = weight (kg)/height (m)2.&#xD;
&#xD;
          -  Has been practicing social distancing for at least two weeks prior to planned Day 1&#xD;
             vaccination and has no close contacts with known active severe acute respiratory&#xD;
             syndrome coronavirus (SARS-CoV)-2 infection in that time period.&#xD;
&#xD;
          -  Sentinel trial participants ONLY (Panel A, Panel B, and the first 5 participants of&#xD;
             Panel E): Seronegative for SARS-COV-2.&#xD;
&#xD;
          -  Is male or female, from 18 years to 55 years of age (inclusive) (Parts 1 and 2A) or&#xD;
             &gt;55 years of age (Part 2B), at the time of providing documented informed consent.&#xD;
&#xD;
          -  Male participants are eligible to participate if they agree to refrain from donating&#xD;
             sperm during the intervention period and for at least 6 months after the last dose of&#xD;
             study intervention, be abstinent from heterosexual intercourse as their preferred and&#xD;
             usual lifestyle and agree to remain abstinent OR agree to use contraception unless&#xD;
             confirmed to be azoospermic .&#xD;
&#xD;
          -  Contraceptive use by men and women should be consistent with local regulations&#xD;
             regarding the methods of contraception for those participating in clinical studies.&#xD;
&#xD;
          -  A female participant is eligible to participate if she is not pregnant or&#xD;
             breastfeeding, is not a woman of childbearing potential (WOCBP) or Is a WOCBP and&#xD;
             using an acceptable contraceptive method or be abstinent from heterosexual intercourse&#xD;
             as their preferred and usual lifestyle.&#xD;
&#xD;
          -  A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as&#xD;
             required by local regulations) before the first dose of study intervention. If a urine&#xD;
             test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy&#xD;
             test is required. In such cases, the participant must be excluded from participation&#xD;
             if the serum pregnancy result is positive.&#xD;
&#xD;
          -  Refrain from donating oocyte during the intervention period and for at least 6 months&#xD;
             after the last dose of study intervention.&#xD;
&#xD;
          -  The investigator is responsible for review of medical history, menstrual history, and&#xD;
             recent sexual activity to decrease the risk for inclusion of a woman with an early&#xD;
             undetected pregnancy.&#xD;
&#xD;
          -  The participant (or legally acceptable representative) has provided documented&#xD;
             informed consent/assent for the study, including for future biomedical research.&#xD;
&#xD;
          -  Is willing to comply with the study restrictions, including social distancing between&#xD;
             screening and randomization.&#xD;
&#xD;
          -  Is willing to abstain from donating whole blood or blood derivatives, tissue or organ&#xD;
             all along the study.&#xD;
&#xD;
          -  Agrees to provide study personnel with a primary telephone number as well as an&#xD;
             alternate means of contact, if available (such as an alternate telephone number or&#xD;
             email) for follow-up purposes.&#xD;
&#xD;
          -  Can read, understand, and complete the Vaccination Report Card.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Is currently actively infected with SARS-CoV-2 (confirmed by polymerase chain&#xD;
             reaction;[PCR]).&#xD;
&#xD;
          -  Has prior medical history of confirmed SARS-CoV-2 infection or known exposure to an&#xD;
             individual with confirmed coronavirus disease 2019 (COVID-19) disease or SARS CoV-2&#xD;
             infection within the past 2 weeks. With the exception of the sentinel participants&#xD;
             (Panel A, Panel B, and the first 5 participants of Panel E), study participants will&#xD;
             not be screened for enrollment by SARS-CoV-2 serology, allowing those who may have had&#xD;
             a prior asymptomatic SARS-CoV-2 infection to be enrolled.&#xD;
&#xD;
          -  Has a history of severe adverse reactions to vaccine administration, including&#xD;
             anaphylaxis and related symptoms, such as urticaria, respiratory difficulty,&#xD;
             angioedema and abdominal pain to vaccines, or history of known or suspected allergic&#xD;
             reaction likely to be exacerbated by any component of the COVID-19 vaccine.&#xD;
&#xD;
          -  Is currently (or highly suspected to be) immunocompromised, including anticipating the&#xD;
             need for systemic immunosuppressive treatment within the next 6 months or 12 months&#xD;
             for 2-dose Day 1, Day 169 panels or has been diagnosed or highly suspected as having a&#xD;
             congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic&#xD;
             lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA),&#xD;
             inflammatory bowel disease, or other autoimmune condition that could impact the immune&#xD;
             response or the safety of the study vaccine.&#xD;
&#xD;
          -  Has clinically significant thrombocytopenia or other coagulation disorder&#xD;
             contraindicating intramuscular vaccination or repeated venipuncture.&#xD;
&#xD;
          -  Has history or current evidence of any condition, therapy, laboratory abnormality, or&#xD;
             other circumstance that might expose the participant to risk by participating in the&#xD;
             study, confound the results of the study or interfere with the participant's&#xD;
             participation for the full duration of the study.&#xD;
&#xD;
          -  Has a history or presence of clinically significant pulmonary disorders (e.g. chronic&#xD;
             obstructive pulmonary disease [COPD], etc.), or asthma.&#xD;
&#xD;
          -  Has a history of confirmed SARS-CoV-1 or Middle Eastern respiratory syndrome (MERS)&#xD;
&#xD;
          -  Has a history of or current clinically significant medical condition that puts or may&#xD;
             put a participant at increased risk for severe SARS-CoV-2 disease, such as conditions&#xD;
             associated with increased risk of severe illness from COVID-19, cancer, chronic kidney&#xD;
             disease, COPD, immunocompromised state (weakened immune system) from solid organ&#xD;
             transplant, obesity (BMI of 30 or higher), serious heart conditions, such as heart&#xD;
             failure, coronary artery disease, or cardiomyopathies, sickle cell disease, Type 2&#xD;
             diabetes mellitus, asthma, cerebrovascular disease, cystic fibrosis, hypertension or&#xD;
             high blood pressure, an immunocompromised state (weakened immune system), neurologic&#xD;
             conditions, such as dementia, liver disease, pregnancy, pulmonary fibrosis (having&#xD;
             damaged or scarred lung tissues), smoking, thalassemia (a type of blood disorder), or&#xD;
             Type 1 diabetes mellitus.&#xD;
&#xD;
          -  Part 2B ONLY: Older adult participants having mild, well controlled hypertension as is&#xD;
             widely characteristic of aging are allowed if their medication regimens have not&#xD;
             substantively changed for the past 6 months, hypertension has not led to&#xD;
             hospitalization or currently increased rate of clinic visits over the past year, and&#xD;
             hypertension has not been confirmed as putting subjects at increased risk of severe&#xD;
             illness from COVID-19 by the CDC&#xD;
             (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-higher-ris&#xD;
             k.html).&#xD;
&#xD;
          -  Is mentally or legally incapacitated, has significant emotional problems at the time&#xD;
             of pre-study (screening) visit or expected during the conduct of the study or has a&#xD;
             history of clinically significant psychiatric disorder of the last 5 years.&#xD;
&#xD;
          -  Has a history of any clinically significant major neurological disorders or seizures&#xD;
             (including Guillain-Barré syndrome), with the exception of febrile seizures during&#xD;
             childhood.&#xD;
&#xD;
          -  Has a history of cancer (malignancy)&#xD;
&#xD;
          -  Has a known or suspected history of significant multiple and/or severe allergies&#xD;
             (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant&#xD;
             intolerability (i.e., systemic allergic reaction) to prescription or non-prescription&#xD;
             drugs or food.&#xD;
&#xD;
          -  Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human&#xD;
             immunodeficiency virus (HIV)-1 or 2 antibodies. Individuals with antibodies to&#xD;
             hepatitis C may be enrolled if hepatitis C viral load is undetectable and there is no&#xD;
             evidence of or history of liver disease.&#xD;
&#xD;
          -  Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4&#xD;
             weeks prior to the pre-study (screening) visit.&#xD;
&#xD;
          -  Has received immunosuppressive drugs (like e.g. systemic corticosteroids, excluding&#xD;
             topical preparations and inhalers) within 3 months prior to the first vaccination or 6&#xD;
             months for chemotherapies.&#xD;
&#xD;
          -  *Has received vaccination within 4 weeks prior to first vaccination or is planning to&#xD;
             receive a licensed vaccine 4 weeks before or after each study vaccination (e.g.&#xD;
&#xD;
        Inactivated influenza vaccine).&#xD;
&#xD;
          -  *Has received measles-containing vaccine within 3 months prior to the first&#xD;
             vaccination.&#xD;
&#xD;
          -  Has received a blood transfusion or blood products, including immunoglobulin, starting&#xD;
             from 3 months before the first study vaccination or is scheduled to receive a blood&#xD;
             transfusion or blood product through study completion. Autologous blood transfusions&#xD;
             are not considered an exclusion criterion.&#xD;
&#xD;
          -  Is unable to meet the concomitant medication restrictions&#xD;
&#xD;
          -  Is using antiviral medications or any investigational agents for prophylaxis of&#xD;
             SARSCoV-2 within 4 weeks prior to the first vaccination.&#xD;
&#xD;
          -  Has ever participated in an investigational study of a SARS-CoV-2 vaccine, or an&#xD;
             antiviral or other biologic product intended for the treatment of COVID-19.&#xD;
&#xD;
          -  Is currently participating in any study of a vaccine or investigational medicinal&#xD;
             product (IMP) or has recently completed participation in another study of a vaccine or&#xD;
             IMP and received a vaccine within 3 months prior to screening or an IMP within 4 weeks&#xD;
             (or 5 half-lives of the IMP, whichever is longer) prior to the pre-study (screening)&#xD;
             visit. The window will be derived from the date of the last study intervention (e.g.,&#xD;
             receiving a vaccine or IMP) in the previous study to the date of the pre-study&#xD;
             (screening) visit for this study. In addition, a participant cannot participate in&#xD;
             another investigational trial up to the post-trial visit of this study (approximately&#xD;
             12 months after the last study vaccination).&#xD;
&#xD;
          -  Has glycated hemoglobin (A1C) ≥ 6.5% at screening.&#xD;
&#xD;
          -  Has a history of alcohol, cocaine, or opioid abuse during the previous 3 years.&#xD;
&#xD;
          -  Participants who currently smoke or used nicotine or nicotine-containing products&#xD;
             (e.g. nicotine patch) within last 3 months. Former smokers that have less than a 10&#xD;
             pack-year history of smoking and have not smoked in the last 12 months are eligible to&#xD;
             be enrolled.&#xD;
&#xD;
          -  Has a tattoo, scar or other physical finding at the area of the vaccination site that&#xD;
             would interfere with intramuscular injection or a local tolerability assessment.&#xD;
&#xD;
          -  Presents any concern by the investigator regarding safe participation in the study or&#xD;
             for any other reason the investigator considers the participant inappropriate for&#xD;
             participation in the study.&#xD;
&#xD;
          -  Lives in a nursing home or long-term care facility.&#xD;
&#xD;
          -  Is currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g.,&#xD;
             health care worker with direct patient contact, emergency response personnel), or, at&#xD;
             the investigator's discretion to be at increased risk to acquire SARS-CoV-2 for any&#xD;
             other reason.&#xD;
&#xD;
          -  Individuals who are living and/or working with severely immunocompromised people,&#xD;
             pregnant women, lactating women, children under 12 months old, or any other individual&#xD;
             that, in the judgment of the investigator, might be at increased risk.&#xD;
&#xD;
          -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or&#xD;
             child) who is investigatively involved with this study.&#xD;
&#xD;
               -  if the participant meets these exclusion criteria, the Day 1 Visit may be&#xD;
                  rescheduled for a time when these criteria are not met.&#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>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Centers of America, LLC ( Site 0014)</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Multispecialty Research, LLC ( Site 0013)</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Kentucky Research Associates, Inc. ( Site 0011)</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Pharmaceutical Research PC ( Site 0012)</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI-CCCIT GesmbH ( Site 0006)</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Wien ( Site 0007)</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent ( Site 0003)</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SGS Life Science Services ( Site 0001)</name>
      <address>
        <city>Antwerpen</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ATC - Clinical Pharmacology Unit ( Site 0002)</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <results_first_submitted>December 20, 2021</results_first_submitted>
  <results_first_submitted_qc>December 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 23, 2021</results_first_posted>
  <last_update_submitted>December 20, 2021</last_update_submitted>
  <last_update_submitted_qc>December 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT04498247/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Healthy adults with no prior history of confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, or known exposure to an individual with confirmed Coronavirus Disease 2019 (COVID-19) or SARS-CoV-2 infection were enrolled in this study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>V591 1×10^4 TCID50-1 Dose</title>
          <description>Participants received one dose of V591 1x10^4 tissue culture infectious dose (TCID50) on Day 1</description>
        </group>
        <group group_id="P2">
          <title>V591 1×10^5 TCID50-1 Dose</title>
          <description>Participants received one dose of V591 1×10^5 TCID50 on Day 1.</description>
        </group>
        <group group_id="P3">
          <title>V591 1x10^5 TCID50- 2 Dose</title>
          <description>Participants received one dose of V591 1×10^5 TCID50 on Day 1 and a second V591 1×10^5 TCID50 dose on Day 57.</description>
        </group>
        <group group_id="P4">
          <title>V591 1×10^6 TCID50-1 Dose</title>
          <description>Participants received one dose of V591 1×10^6 TCID50 on Day 1</description>
        </group>
        <group group_id="P5">
          <title>V591 1×10^6 TCID50-2 Dose</title>
          <description>Participants received one dose of V591 1×10^6 TCID50 on Day 1 and a second V591 1×10^6 TCID50 dose on Day 57.</description>
        </group>
        <group group_id="P6">
          <title>V591 1×10^7 TCID50</title>
          <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
        </group>
        <group group_id="P7">
          <title>Placebo- 1 Dose</title>
          <description>Participants received one dose of placebo on Day 1</description>
        </group>
        <group group_id="P8">
          <title>Placebo- 2 Dose</title>
          <description>Participants received one dose of placebo on Day 1 and a second dose of placebo on Day 57.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="80"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="81"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="20"/>
                <participants group_id="P7" count="51"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 1</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="80"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="81"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="20"/>
                <participants group_id="P7" count="51"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 2</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="68"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="70"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="20"/>
                <participants group_id="P7" count="43"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="8"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Mistakenly Randomized; Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Received a non-study COVID-19 vaccine.</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="7"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>V591 1×10^4 TCID50-1 Dose</title>
          <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
        </group>
        <group group_id="B2">
          <title>V591 1×10^5 TCID50- 1 Dose</title>
          <description>Participants received one dose of V591 1×10^5 TCID50 on Day 1.</description>
        </group>
        <group group_id="B3">
          <title>V591 1x10^5 TCID50- 2 Dose</title>
          <description>Participants received one dose of V591 1×10^5 TCID50 on Day 1 and a second V591 1×10^5 TCID50 dose on Day 57.</description>
        </group>
        <group group_id="B4">
          <title>V591 1×10^6 TCID50-1 Dose</title>
          <description>Participants received one dose of V591 1×10^6 TCID50 on Day 1.</description>
        </group>
        <group group_id="B5">
          <title>V591 1×10^6 TCID50-2 Dose</title>
          <description>Participants received one dose of V591 1×10^6 TCID50 on Day 1 and a second V591 1×10^6 TCID50 dose on Day 57.</description>
        </group>
        <group group_id="B6">
          <title>V591 1×10^7 TCID50</title>
          <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
        </group>
        <group group_id="B7">
          <title>Placebo - 1 Dose</title>
          <description>Participants received one dose of placebo on Day 1.</description>
        </group>
        <group group_id="B8">
          <title>Placebo- 2 Dose</title>
          <description>Participants received one dose of placebo on Day 1 and a second dose of placebo on Day 57.</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="80"/>
            <count group_id="B3" value="4"/>
            <count group_id="B4" value="81"/>
            <count group_id="B5" value="4"/>
            <count group_id="B6" value="20"/>
            <count group_id="B7" value="51"/>
            <count group_id="B8" value="2"/>
            <count group_id="B9" value="263"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.7" spread="10.4"/>
                    <measurement group_id="B2" value="59.7" spread="14.8"/>
                    <measurement group_id="B3" value="45.0" spread="6.6"/>
                    <measurement group_id="B4" value="58.4" spread="15.2"/>
                    <measurement group_id="B5" value="40.3" spread="13.2"/>
                    <measurement group_id="B6" value="26.6" spread="6.8"/>
                    <measurement group_id="B7" value="56.2" spread="17.9"/>
                    <measurement group_id="B8" value="34.5" spread="0.7"/>
                    <measurement group_id="B9" value="53.8" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="43"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="14"/>
                    <measurement group_id="B7" value="27"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="24"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="69"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="20"/>
                    <measurement group_id="B7" value="48"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="226"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="78"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="20"/>
                    <measurement group_id="B7" value="50"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="254"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One Solicited Injection Site Adverse Event (AE) After Any Study Intervention</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection site AEs of pain/tenderness, swelling, and redness/erythema were assessed.</description>
        <time_frame>Up to 5 days after any study intervention</time_frame>
        <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
        <group_list>
          <group group_id="O1">
            <title>V591 1×10^4 TCID50</title>
            <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
          </group>
          <group group_id="O2">
            <title>V591 1×10^5 TCID50</title>
            <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O3">
            <title>V591 1×10^6 TCID50</title>
            <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O4">
            <title>V591 1×10^7 TCID50</title>
            <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Solicited Injection Site Adverse Event (AE) After Any Study Intervention</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection site AEs of pain/tenderness, swelling, and redness/erythema were assessed.</description>
          <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Following Vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="6.0"/>
                    <measurement group_id="O3" value="15.3"/>
                    <measurement group_id="O4" value="55.0"/>
                    <measurement group_id="O5" value="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Following Vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="25.0"/>
                    <measurement group_id="O5" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One Solicited Systemic AE After Any Study Intervention</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Systemic AEs of fever, muscle pain, joint pain, headache, fatigue, rash, or nausea were assessed.</description>
        <time_frame>Up to 14 days after any study intervention</time_frame>
        <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
        <group_list>
          <group group_id="O1">
            <title>V591 1×10^4 TCID50</title>
            <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
          </group>
          <group group_id="O2">
            <title>V591 1×10^5 TCID50</title>
            <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O3">
            <title>V591 1×10^6 TCID50</title>
            <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O4">
            <title>V591 1×10^7 TCID50</title>
            <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Solicited Systemic AE After Any Study Intervention</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Systemic AEs of fever, muscle pain, joint pain, headache, fatigue, rash, or nausea were assessed.</description>
          <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Following Vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="45.2"/>
                    <measurement group_id="O3" value="37.6"/>
                    <measurement group_id="O4" value="65.0"/>
                    <measurement group_id="O5" value="56.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Following Vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="25.0"/>
                    <measurement group_id="O3" value="75.0"/>
                    <measurement group_id="O5" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One Unsolicited Adverse Event After Any Study Intervention</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All unsolicited AEs were assessed.</description>
        <time_frame>Up to 28 days after any study intervention</time_frame>
        <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
        <group_list>
          <group group_id="O1">
            <title>V591 1×10^4 TCID50</title>
            <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
          </group>
          <group group_id="O2">
            <title>V591 1×10^5 TCID50</title>
            <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O3">
            <title>V591 1×10^6 TCID50</title>
            <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O4">
            <title>V591 1×10^7 TCID50</title>
            <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Unsolicited Adverse Event After Any Study Intervention</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All unsolicited AEs were assessed.</description>
          <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Following Vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.0"/>
                    <measurement group_id="O2" value="34.5"/>
                    <measurement group_id="O3" value="32.9"/>
                    <measurement group_id="O4" value="70.0"/>
                    <measurement group_id="O5" value="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Following Vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="25.0"/>
                    <measurement group_id="O5" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least 1 Serious Adverse Event</title>
        <description>An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.</description>
        <time_frame>Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)</time_frame>
        <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
        <group_list>
          <group group_id="O1">
            <title>V591 1×10^4 TCID50</title>
            <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
          </group>
          <group group_id="O2">
            <title>V591 1×10^5 TCID50</title>
            <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O3">
            <title>V591 1×10^6 TCID50</title>
            <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O4">
            <title>V591 1×10^7 TCID50</title>
            <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least 1 Serious Adverse Event</title>
          <description>An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.</description>
          <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Following Vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="2.4"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Following Vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.</description>
        <time_frame>Up to 57 days</time_frame>
        <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
        <group_list>
          <group group_id="O1">
            <title>V591 1×10^4 TCID50</title>
            <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
          </group>
          <group group_id="O2">
            <title>V591 1×10^5 TCID50</title>
            <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O3">
            <title>V591 1×10^6 TCID50</title>
            <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O4">
            <title>V591 1×10^7 TCID50</title>
            <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.</description>
          <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Following Vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="6.0"/>
                    <measurement group_id="O3" value="4.7"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Following Vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least 1 Medically Attended Adverse Event (MAAE)</title>
        <description>A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason.</description>
        <time_frame>Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)</time_frame>
        <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
        <group_list>
          <group group_id="O1">
            <title>V591 1×10^4 TCID50</title>
            <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
          </group>
          <group group_id="O2">
            <title>V591 1×10^5 TCID50</title>
            <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O3">
            <title>V591 1×10^6 TCID50</title>
            <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O4">
            <title>V591 1×10^7 TCID50</title>
            <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least 1 Medically Attended Adverse Event (MAAE)</title>
          <description>A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason.</description>
          <population>All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Following Vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0"/>
                    <measurement group_id="O2" value="10.7"/>
                    <measurement group_id="O3" value="11.8"/>
                    <measurement group_id="O4" value="40.0"/>
                    <measurement group_id="O5" value="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Following Vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)</title>
        <description>Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a constrained longitudinal data analysis (cLDA) method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.</description>
        <time_frame>Days 1, 15, 29, 57, 71, and 85</time_frame>
        <population>All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.</population>
        <group_list>
          <group group_id="O1">
            <title>V591 1×10^4 TCID50</title>
            <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
          </group>
          <group group_id="O2">
            <title>V591 1×10^5 TCID50</title>
            <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O3">
            <title>V591 1×10^6 TCID50</title>
            <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O4">
            <title>V591 1×10^7 TCID50</title>
            <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)</title>
          <description>Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a constrained longitudinal data analysis (cLDA) method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.</description>
          <population>All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="5.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="6.3" lower_limit="5.1" upper_limit="7.8"/>
                    <measurement group_id="O3" value="5.9" lower_limit="5.0" upper_limit="6.9"/>
                    <measurement group_id="O4" value="9.1" lower_limit="5.0" upper_limit="16.7"/>
                    <measurement group_id="O5" value="5.0" lower_limit="5.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="4.2" upper_limit="8.1"/>
                    <measurement group_id="O2" value="6.7" lower_limit="5.3" upper_limit="8.5"/>
                    <measurement group_id="O3" value="7.9" lower_limit="6.1" upper_limit="10.4"/>
                    <measurement group_id="O4" value="53.1" lower_limit="17.2" upper_limit="164.6"/>
                    <measurement group_id="O5" value="5.3" lower_limit="4.7" upper_limit="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="5.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="8.3" lower_limit="6.0" upper_limit="11.3"/>
                    <measurement group_id="O3" value="8.3" lower_limit="6.3" upper_limit="11.0"/>
                    <measurement group_id="O4" value="31.2" lower_limit="11.2" upper_limit="86.7"/>
                    <measurement group_id="O5" value="6.3" lower_limit="4.8" upper_limit="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="13.7" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="5.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="5.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="25.7" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="45.2" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="5.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="24.6" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="54.2" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="5.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)</title>
        <description>Serum samples were collected and the concentrations of total anti-spike IgG antibodies were assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.</description>
        <time_frame>Days 1, 15, 29, 57, 71, and 85</time_frame>
        <population>All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.</population>
        <group_list>
          <group group_id="O1">
            <title>V591 1×10^4 TCID50</title>
            <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
          </group>
          <group group_id="O2">
            <title>V591 1×10^5 TCID50</title>
            <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O3">
            <title>V591 1×10^6 TCID50</title>
            <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O4">
            <title>V591 1×10^7 TCID50</title>
            <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)</title>
          <description>Serum samples were collected and the concentrations of total anti-spike IgG antibodies were assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.</description>
          <population>All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.</population>
          <units>ELISA unit/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="82"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2" lower_limit="25.2" upper_limit="25.2"/>
                    <measurement group_id="O2" value="33.9" lower_limit="26.1" upper_limit="44.0"/>
                    <measurement group_id="O3" value="36.3" lower_limit="28.2" upper_limit="46.9"/>
                    <measurement group_id="O4" value="46.3" lower_limit="24.7" upper_limit="86.8"/>
                    <measurement group_id="O5" value="26.1" lower_limit="24.8" upper_limit="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" lower_limit="24.1" upper_limit="28.5"/>
                    <measurement group_id="O2" value="35.7" lower_limit="27.2" upper_limit="46.7"/>
                    <measurement group_id="O3" value="41.6" lower_limit="30.0" upper_limit="57.6"/>
                    <measurement group_id="O4" value="239.2" lower_limit="78.8" upper_limit="725.9"/>
                    <measurement group_id="O5" value="26.4" lower_limit="24.7" upper_limit="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" lower_limit="23.7" upper_limit="34.6"/>
                    <measurement group_id="O2" value="44.0" lower_limit="31.6" upper_limit="61.3"/>
                    <measurement group_id="O3" value="52.6" lower_limit="36.6" upper_limit="75.6"/>
                    <measurement group_id="O4" value="294.8" lower_limit="110.3" upper_limit="788.2"/>
                    <measurement group_id="O5" value="31.5" lower_limit="25.3" upper_limit="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="97.7" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="25.2" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="25.2" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="184.7" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="336.1" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="25.2" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="180.8" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="260.6" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="25.2" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA</title>
        <description>Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).</description>
        <time_frame>Days 1, 15, 29, 57, 71, and 85</time_frame>
        <population>All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.</population>
        <group_list>
          <group group_id="O1">
            <title>V591 1×10^4 TCID50</title>
            <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
          </group>
          <group group_id="O2">
            <title>V591 1×10^5 TCID50</title>
            <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O3">
            <title>V591 1×10^6 TCID50</title>
            <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O4">
            <title>V591 1×10^7 TCID50</title>
            <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA</title>
          <description>Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).</description>
          <population>All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.9" upper_limit="1.4"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.1" upper_limit="1.5"/>
                    <measurement group_id="O4" value="4.1" lower_limit="2.0" upper_limit="8.3"/>
                    <measurement group_id="O5" value="1.1" lower_limit="0.9" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.0" upper_limit="1.5"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.1" upper_limit="1.6"/>
                    <measurement group_id="O4" value="2.6" lower_limit="1.2" upper_limit="5.5"/>
                    <measurement group_id="O5" value="1.2" lower_limit="1.0" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.3" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="1.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="1.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.6" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="4.5" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="1.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.5" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="5.4" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="1.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA</title>
        <description>Serum samples were collected and the total anti-spike IgG antibodies assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).</description>
        <time_frame>Days 1, 15, 29, 57, 71, and 85</time_frame>
        <population>All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.</population>
        <group_list>
          <group group_id="O1">
            <title>V591 1×10^4 TCID50</title>
            <description>Participants received one dose of V591 1x10^4 TCID50 on Day 1</description>
          </group>
          <group group_id="O2">
            <title>V591 1×10^5 TCID50</title>
            <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O3">
            <title>V591 1×10^6 TCID50</title>
            <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
          </group>
          <group group_id="O4">
            <title>V591 1×10^7 TCID50</title>
            <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA</title>
          <description>Serum samples were collected and the total anti-spike IgG antibodies assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).</description>
          <population>All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.3"/>
                    <measurement group_id="O4" value="3.5" lower_limit="1.8" upper_limit="6.9"/>
                    <measurement group_id="O5" value="1.0" lower_limit="0.9" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.0" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.1" upper_limit="1.6"/>
                    <measurement group_id="O4" value="3.9" lower_limit="1.8" upper_limit="8.6"/>
                    <measurement group_id="O5" value="1.2" lower_limit="1.0" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.3" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="1.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="1.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5.2" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="6.7" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="1.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5.1" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O3" value="5.2" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                    <measurement group_id="O5" value="1.0" lower_limit="NA" upper_limit="NA">The 95% confidence interval is not provided when n is less than 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.</time_frame>
      <desc>The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.</desc>
      <group_list>
        <group group_id="E1">
          <title>V591 1x10⁴ TCID₅₀-Post Vaccination (Vacc) 1</title>
          <description>Participants received one dose of 1x10^4 TCID50 V591 on Day 1</description>
        </group>
        <group group_id="E2">
          <title>V591 1x10⁵ TCID₅₀-Post Vacc 1</title>
          <description>All participants received one dose of V591 1×10^5 TCID50 on Day 1; Some participants received a second V591 1×10^5 TCID50 dose on Day 57.</description>
        </group>
        <group group_id="E3">
          <title>V591 1x10⁶ TCID₅₀-Post Vacc 1</title>
          <description>All participants received one dose of V591 1×10^6 TCID50 on Day 1; Some participants received a second V591 1×10^6 TCID50 dose on Day 57.</description>
        </group>
        <group group_id="E4">
          <title>V591 1x10⁷ TCID₅₀-Post Vacc 1</title>
          <description>Participants received one dose of V591 1×10^7 TCID50 on Day 1</description>
        </group>
        <group group_id="E5">
          <title>Placebo-Post Vacc 1</title>
          <description>Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.</description>
        </group>
        <group group_id="E6">
          <title>V591 1x10⁵ TCID₅₀-Post Vacc 2</title>
          <description>All participants received 2 doses of V591; one dose of V591 1×10^5 TCID50 on Day 1 and a second dose of V591 1×10^5 TCID50 on Day 57.</description>
        </group>
        <group group_id="E7">
          <title>V591 1x10⁶ TCID₅₀-Post Vacc 2</title>
          <description>All participants received 2 doses of V591; one dose of V591 1×10^6 TCID50 on Day 1 and a second dose of V591 1×10^6 TCID50 on Day 57.</description>
        </group>
        <group group_id="E8">
          <title>Placebo-Post Vacc 2</title>
          <description>All participants received 2 doses of placebo; one dose of placebo on Day 1 and a second dose of placebo on Day 57.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="84"/>
                <counts group_id="E3" subjects_affected="41" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="35" subjects_at_risk="53"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="84"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="14" subjects_affected="8" subjects_at_risk="20"/>
                <counts group_id="E2" events="30" subjects_affected="22" subjects_at_risk="84"/>
                <counts group_id="E3" events="25" subjects_affected="19" subjects_at_risk="85"/>
                <counts group_id="E4" events="13" subjects_affected="8" subjects_at_risk="20"/>
                <counts group_id="E5" events="26" subjects_affected="20" subjects_at_risk="53"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site movement impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="84"/>
                <counts group_id="E3" events="14" subjects_affected="13" subjects_at_risk="85"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="20"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Puncture site haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="84"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Exposure to SARS-CoV-2</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="84"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="84"/>
                <counts group_id="E3" events="15" subjects_affected="14" subjects_at_risk="85"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E5" events="14" subjects_affected="10" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E2" events="34" subjects_affected="24" subjects_at_risk="84"/>
                <counts group_id="E3" events="31" subjects_affected="20" subjects_at_risk="85"/>
                <counts group_id="E4" events="16" subjects_affected="9" subjects_at_risk="20"/>
                <counts group_id="E5" events="22" subjects_affected="19" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Anosmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated based on an interim assessment of immunogenicity indicating that V591 was not predicted to provide adequate protection against disease caused by SARS-CoV-2.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04498247
org study id: V591-001
secondary id: 2020-003493-46
secondary id: V591-001
nct id: NCT04498247
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this early Phase 1/2 study is to identify the V591 dose that
      achieves the target immune response in humans based on preclinical or early clinical data.
This study was terminated and modifications to the dosing regimens and clinical/laboratory
      procedures were implemented for trial discontinuation according to Protocol Amendment 04. Per
      protocol, certain panels were never enrolled and/or the second dose of study intervention was
      not administered.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Participants With at Least One Solicited Injection Site Adverse Event (AE) After Any Study Intervention
time frame: Up to 5 days after any study intervention
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection site AEs of pain/tenderness, swelling, and redness/erythema were assessed.
measure: Percentage of Participants With at Least One Solicited Systemic AE After Any Study Intervention
time frame: Up to 14 days after any study intervention
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Systemic AEs of fever, muscle pain, joint pain, headache, fatigue, rash, or nausea were assessed.
measure: Percentage of Participants With at Least One Unsolicited Adverse Event After Any Study Intervention
time frame: Up to 28 days after any study intervention
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All unsolicited AEs were assessed.
measure: Percentage of Participants With at Least 1 Serious Adverse Event
time frame: Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)
description: An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
measure: Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event
time frame: Up to 57 days
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
measure: Percentage of Participants With at Least 1 Medically Attended Adverse Event (MAAE)
time frame: Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)
description: A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason.
measure: Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)
time frame: Days 1, 15, 29, 57, 71, and 85
description: Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a constrained longitudinal data analysis (cLDA) method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
measure: Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
time frame: Days 1, 15, 29, 57, 71, and 85
description: Serum samples were collected and the concentrations of total anti-spike IgG antibodies were assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
measure: Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA
time frame: Days 1, 15, 29, 57, 71, and 85
description: Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).
measure: Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA
time frame: Days 1, 15, 29, 57, 71, and 85
description: Serum samples were collected and the total anti-spike IgG antibodies assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).
arm group label: Panel A
arm group type: Experimental
description: Participants in this 18 to 55 year old sentinel cohort will receive 2 doses (Day 1 and Day 57) of 1x10^5 50% tissue culture infectious dose (TCID50) V591 or placebo
arm group label: Panel B
arm group type: Experimental
description: Participants in this 18 to 55 year old sentinel cohort will receive 2 doses (Days 1 and 57) of 1x10^6 TCID50 V591 or placebo
arm group label: Panels C, G
arm group type: Experimental
description: Participants in this 18 to 55 year old cohort (Panel C) or >55 year old cohort (Panel G) will receive 1 dose of 1x10^5 TCID50 V591 or placebo.
arm group label: Panels D, H
arm group type: Experimental
description: Participants in this 18 to 55 year old cohort (Panel D) or >55 year old cohort (Panel H) will receive 1 dose of 1x10^6 TCID50 V591 or placebo.
arm group label: Panel E
arm group type: Experimental
description: Participants in this 18 to 55 year old cohort will receive 1 dose of 1x10^7 V591 or placebo.
arm group label: Panel F
arm group type: Experimental
description: Participants in this 18 to 55 year old cohort will receive 2 doses (Days 1 and 169) of V591 or placebo. Day 1 will be 1x10^4 TCID50 V591 or placebo and Day 169 will be 1x10^5 TCID50 V591 or placebo.
arm group label: Panel I
arm group type: Experimental
description: Participants in this >55 year old cohort will receive 2 doses (Days 1 and 57) of 1x10^5 TCID50 V591 or placebo
arm group label: Panel J
arm group type: Experimental
description: Participants in this >55 year old cohort will receive 2 doses (Days 1 and 57) of 1x10^6 TCID50 V591 or placebo
arm group label: Panel K
arm group type: Experimental
description: Participants in this >55 year old cohort will receive 2 doses (Days 1 and 169) of 1x10^5 TCID50 V591 or placebo
arm group label: Panel L
arm group type: Experimental
description: Participants in this >55 year old cohort will receive 2 doses (Days 1 and 169) of 1x10^6 TCID50 V591 or placebo
intervention type: Biological
intervention name: V591
description: 1 or 2 ascending doses of V591 will be administered via intramuscular (IM) injection.
arm group label: Panel A
arm group label: Panel B
arm group label: Panel E
arm group label: Panel F
arm group label: Panel I
arm group label: Panel J
arm group label: Panel K
arm group label: Panel L
arm group label: Panels C, G
arm group label: Panels D, H
intervention type: Other
intervention name: Placebo
description: Placebo (0.9% sodium chloride) administered via IM injection.
arm group label: Panel A
arm group label: Panel B
arm group label: Panel E
arm group label: Panel F
arm group label: Panel I
arm group label: Panel J
arm group label: Panel K
arm group label: Panel L
arm group label: Panels C, G
arm group label: Panels D, H
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Belgium
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated based on an interim assessment of immunogenicity indicating that V591 was not predicted to provide adequate protection against disease caused by SARS-CoV-2.
point of contact: 