<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/NCT04449276</url>
  </required_header>
  <id_info>
    <org_study_id>CV-NCOV-001</org_study_id>
    <secondary_id>2020-001286-36</secondary_id>
    <nct_id>NCT04449276</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19</brief_title>
  <official_title>COVID-19: A Phase 1, Partially Blind, Placebo-controlled, Dose Escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CureVac</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coalition for Epidemic Preparedness Innovations</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CureVac</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose&#xD;
      administrations of CVnCoV at different dose levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Funded by Coalition for Epidemic Preparedness Innovations (CEPI).&#xD;
&#xD;
      This clinical trial information was submitted voluntarily under the applicable law and,&#xD;
      therefore, certain submission deadlines may not apply. (That is, clinical trial information&#xD;
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public&#xD;
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by&#xD;
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">December 21, 2021</completion_date>
  <primary_completion_date type="Actual">December 21, 2021</primary_completion_date>
  <phase>Phase 1</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>Single (Outcomes Assessor)</masking>
    <masking_description>In the initial part of the dose escalation, participants will be enrolled in sentinel groups in an open manner. In the second part, participants will be enrolled in placebo-controlled groups in an observer-blind manner.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination</measure>
    <time_frame>Up to 24 hours after vaccination on Day 1</time_frame>
    <description>Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination</measure>
    <time_frame>Up to 60 hours after vaccination on Day 1</time_frame>
    <description>Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Local Adverse Events</measure>
    <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36)</time_frame>
    <description>Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale</measure>
    <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
    <description>Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Solicited Local Adverse Events</measure>
    <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
    <description>Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Systemic Adverse Events</measure>
    <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
    <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale</measure>
    <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
    <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Solicited Systemic Adverse Events</measure>
    <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
    <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine</measure>
    <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
    <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited Adverse Events</measure>
    <time_frame>Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)</time_frame>
    <description>Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intensity of Unsolicited Adverse Events Assessed by the Investigator</measure>
    <time_frame>Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)</time_frame>
    <description>Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:&#xD;
Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.&#xD;
Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities.&#xD;
Severe: an event that prevented normal everyday activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine</measure>
    <time_frame>Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)</time_frame>
    <description>Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With One or More Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline to Day 393</time_frame>
    <description>An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine</measure>
    <time_frame>Baseline to Day 393</time_frame>
    <description>An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With One or More Adverse Events of Special Interest (AESIs)</measure>
    <time_frame>Day 1 to Day 393</time_frame>
    <description>The following events will be considered as AESIs: adverse events with a suspected immune-mediated etiology, COVID-19 disease and other adverse events relevant to SARS-CoV vaccine development or the target disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies</measure>
    <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
    <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies</measure>
    <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
    <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies</measure>
    <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
    <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies</measure>
    <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
    <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies</measure>
    <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
    <description>Measured using an activity assay. In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. In participants seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies</measure>
    <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
    <description>Measured using an activity assay.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Severe Acute Respiratory Syndrome</condition>
  <condition>Coronavirus</condition>
  <condition>SARS-CoV-2</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Dose Escalation CVnCoV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be vaccinated with CVnCoV at escalating dose levels on Day 1 and Day 29. Safety data will inform the decision to continue enrolling at the current dose level, or to proceed to dose escalation. Initially, dose levels of 2, 4 and 8 μg will be evaluated.&#xD;
Dose levels of 2, 4, 6, 8 and 12µg will be evaluated with potential increase to dose levels up to 20 μg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be given placebo on Day 1 and Day 29.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CVnCoV Vaccine</intervention_name>
    <description>Participants will receive an intramuscular injection by needle in the deltoid area.</description>
    <arm_group_label>Dose Escalation CVnCoV</arm_group_label>
    <other_name>CV07050101</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive an intramuscular injection by needle in the deltoid area.</description>
    <arm_group_label>Dose Escalation Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for all participants:&#xD;
&#xD;
          -  Healthy male and female participants aged 18 to 60 years inclusive. Healthy&#xD;
             participant is defined as an individual who is in good general health, not having any&#xD;
             mental or physical disorder requiring regular or frequent medication.&#xD;
&#xD;
          -  Expected to be compliant with protocol procedures and available for clinical follow-up&#xD;
             through the last planned visit.&#xD;
&#xD;
          -  Physical examination and laboratory results without clinically significant findings&#xD;
             according to the Investigator's assessment.&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥18.0 and ≤30.0kg/m^2 (≥18.0 and ≤32.0kg/m2 for participants&#xD;
             with SARS-CoV-2 positive serology).&#xD;
&#xD;
          -  Females: At the time of enrollment, negative human chorionic gonadotropin (hCG)&#xD;
             pregnancy test (serum) for women presumed to be of childbearing potential on the day&#xD;
             of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (hCG), (only&#xD;
             required if the serum pregnancy test was performed more than 3 days before).&#xD;
&#xD;
          -  Females of childbearing potential must use highly effective methods of birth control&#xD;
             from 1 month before the first administration of the trial vaccine until 3 months&#xD;
             following the last administration. The following methods of birth control are&#xD;
             considered highly effective when used consistently and correctly:&#xD;
&#xD;
               -  Combined (estrogen and progestogen containing) hormonal contraception associated&#xD;
                  with inhibition of ovulation (oral, intravaginal or transdermal);&#xD;
&#xD;
               -  Progestogen-only hormonal contraception associated with inhibition of ovulation&#xD;
                  (oral, injectable or implantable);&#xD;
&#xD;
               -  Intrauterine devices (IUDs);&#xD;
&#xD;
               -  Intrauterine hormone-releasing systems (IUSs);&#xD;
&#xD;
               -  Bilateral tubal occlusion;&#xD;
&#xD;
               -  Vasectomized partner;&#xD;
&#xD;
               -  Sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal&#xD;
                  and post-ovulation methods] and withdrawal are not acceptable).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The following criterion applies to all open-label sentinel participants:&#xD;
&#xD;
          -  Participants with SARS-CoV-2 positive serology as confirmed by testing at enrollment.&#xD;
&#xD;
        The following criteria apply to all participants, except those with SARS-CoV-2 positive&#xD;
        serology:&#xD;
&#xD;
          -  Participants considered at the Investigator's discretion to be at increased risk to&#xD;
             acquire COVID-19 disease (including, but not limited to, health care workers with&#xD;
             direct involvement in patient care or care of long-term care recipients).&#xD;
&#xD;
          -  History of confirmed COVID-19 disease or known exposure to an individual with&#xD;
             confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks.&#xD;
&#xD;
        The following criteria apply to all participants:&#xD;
&#xD;
          -  Use of any investigational or non-registered product (vaccine or drug) other than the&#xD;
             trial vaccine within 28 days preceding the administration of the trial vaccine, or&#xD;
             planned use during the trial period.&#xD;
&#xD;
          -  Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days&#xD;
             (for live vaccines) prior to enrollment in this trial or planned receipt of any&#xD;
             vaccine within 28 days of trial vaccine administration.&#xD;
&#xD;
          -  Receipt of any investigational SARS-CoV-2 or other CoV vaccine prior to the&#xD;
             administration of the trial vaccine.&#xD;
&#xD;
          -  Any treatment with immunosuppressants or other immune-modifying drugs within 6 months&#xD;
             prior to the administration of the trial vaccine or planned use during the trial, with&#xD;
             the exception of topically-applied steroids. Corticosteroids used in the context of&#xD;
             COVID-19 disease of participants with SARS CoV 2 positive serology are not&#xD;
             exclusionary.&#xD;
&#xD;
          -  Any medically diagnosed or suspected immunosuppressive or immunodeficient condition&#xD;
             based on medical history and physical examination, including known human&#xD;
             immunodeficiency virus infection, hepatitis B virus infection and hepatitis C virus&#xD;
             infection.&#xD;
&#xD;
          -  History of a pIMD (potential immune-mediated disease).&#xD;
&#xD;
          -  History of angioedema.&#xD;
&#xD;
          -  Any known allergy, including allergy to any component of CVnCoV or aminoglycoside&#xD;
             antibiotics. A history of hay fever or seasonal allergies (pollinosis) that does not&#xD;
             require current treatment (e.g., anti-histamines) during the vaccination period (1&#xD;
             month before first vaccination until 1 month after last vaccination) is not&#xD;
             exclusionary.&#xD;
&#xD;
          -  History of or current alcohol and/or drug abuse.&#xD;
&#xD;
          -  Participants who are active smokers, were active smokers within the last year&#xD;
             (including any vaping in the last year) or have a total smoking history ≥10 pack&#xD;
             years.&#xD;
&#xD;
          -  Active or currently active SARS-CoV-2 infection as confirmed by reactive PCR within 3&#xD;
             days of first trial vaccine administration.&#xD;
&#xD;
          -  History of confirmed SARS or MERS&#xD;
&#xD;
          -  Administration of immunoglobulins (Igs) and/or any blood products within the 3 months&#xD;
             preceding the administration of any dose of the trial vaccine.&#xD;
&#xD;
          -  Presence or evidence of significant acute or chronic, medical or psychiatric illness.&#xD;
             Significant medical or psychiatric illnesses include but are not limited to:&#xD;
&#xD;
               -  Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma)&#xD;
                  requiring daily medications currently or any treatment of respiratory disease&#xD;
                  exacerbations (e.g., asthma exacerbation) in the last 5 years.&#xD;
&#xD;
               -  Respiratory disease with clinically significant dyspnea in the last 5 years&#xD;
                  (except COVID-19 disease in participants with SARS-CoV-2 positive serology).&#xD;
&#xD;
               -  Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids,&#xD;
                  leukotriene modifiers, long- and short-acting beta agonists, theophylline,&#xD;
                  ipratropium, biologics.&#xD;
&#xD;
               -  Significant cardiovascular disease (e.g., congestive heart failure,&#xD;
                  cardiomyopathy, ischemic heart disease, history of stroke, peripheral artery&#xD;
                  disease, pulmonary embolism) or history of myocarditis or pericarditis as an&#xD;
                  adult.&#xD;
&#xD;
               -  Elevated blood pressure or hypertension, even if well-controlled.&#xD;
&#xD;
               -  Diabetes mellitus type 1 or 2.&#xD;
&#xD;
               -  History of any neurological disorders or seizures including Guillain-Barré&#xD;
                  syndrome, with the exception of febrile seizures during childhood.&#xD;
&#xD;
               -  Current or past malignancy, unless completely resolved without sequelae for &gt;5&#xD;
                  years.&#xD;
&#xD;
          -  Foreseeable non-compliance with protocol as judged by the Investigator.&#xD;
&#xD;
          -  For females: pregnancy or lactation.&#xD;
&#xD;
          -  History of any anaphylactic reactions.&#xD;
&#xD;
          -  Participants with impaired coagulation or any bleeding disorder in whom an IM&#xD;
             injection or a blood draw is contraindicated.&#xD;
&#xD;
          -  Participants employed by the Sponsor, Investigator or trial site, or relatives of&#xD;
             research staff working on this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Ghent</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludwig-Maximilians-Universität München</name>
      <address>
        <city>München</city>
        <state>Bavaria</state>
        <zip>80802</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Hannover (MHH)</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Tübingen Institut für Tropenmedizin</name>
      <address>
        <city>Tübingen</city>
        <zip>72074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <results_first_submitted>April 29, 2022</results_first_submitted>
  <results_first_submitted_qc>April 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 30, 2023</results_first_posted>
  <last_update_submitted>April 29, 2022</last_update_submitted>
  <last_update_submitted_qc>April 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Safety</keyword>
  <keyword>Reactogenicity</keyword>
  <keyword>Immunogenicity</keyword>
  <keyword>Vaccine</keyword>
  <keyword>CEPI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT04449276/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 25, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT04449276/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This trial was performed in Belgium and Germany between June 2020 and December 2021.</recruitment_details>
      <pre_assignment_details>Of the 408 participants who were screened, 280 participants were enrolled.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dose Escalation CVnCoV: 2 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="P2">
          <title>Dose Escalation CVnCoV: 4 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="P3">
          <title>Dose Escalation CVnCoV: 6 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="P4">
          <title>Dose Escalation CVnCoV: 8 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="P5">
          <title>Dose Escalation CVnCoV: 12 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="P6">
          <title>Dose Escalation CVnCoV: 16 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="P7">
          <title>Dose Escalation CVnCoV: 20 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="P8">
          <title>Dose Escalation Placebo</title>
          <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="48"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="28"/>
                <participants group_id="P6" count="16"/>
                <participants group_id="P7" count="12"/>
                <participants group_id="P8" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="46"/>
                <participants group_id="P5" count="26"/>
                <participants group_id="P6" count="16"/>
                <participants group_id="P7" count="12"/>
                <participants group_id="P8" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <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>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dose Escalation CVnCoV: 2 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="B2">
          <title>Dose Escalation CVnCoV: 4 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="B3">
          <title>Dose Escalation CVnCoV: 6 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="B4">
          <title>Dose Escalation CVnCoV: 8 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="B5">
          <title>Dose Escalation CVnCoV: 12 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="B6">
          <title>Dose Escalation CVnCoV: 16 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="B7">
          <title>Dose Escalation CVnCoV: 20 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="B8">
          <title>Dose Escalation Placebo</title>
          <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</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="47"/>
            <count group_id="B2" value="48"/>
            <count group_id="B3" value="48"/>
            <count group_id="B4" value="49"/>
            <count group_id="B5" value="28"/>
            <count group_id="B6" value="16"/>
            <count group_id="B7" value="12"/>
            <count group_id="B8" value="32"/>
            <count group_id="B9" value="280"/>
          </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="38.2" spread="12.48"/>
                    <measurement group_id="B2" value="39.1" spread="13.17"/>
                    <measurement group_id="B3" value="38.6" spread="12.74"/>
                    <measurement group_id="B4" value="38.9" spread="12.87"/>
                    <measurement group_id="B5" value="37.4" spread="13.51"/>
                    <measurement group_id="B6" value="37.4" spread="13.89"/>
                    <measurement group_id="B7" value="39.3" spread="12.11"/>
                    <measurement group_id="B8" value="40.1" spread="13.46"/>
                    <measurement group_id="B9" value="38.7" spread="12.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>18 - 40 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="16"/>
                    <measurement group_id="B9" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>41 - 60 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="16"/>
                    <measurement group_id="B9" value="135"/>
                  </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="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="17"/>
                    <measurement group_id="B9" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="15"/>
                    <measurement group_id="B9" value="165"/>
                  </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="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="49"/>
                    <measurement group_id="B5" value="27"/>
                    <measurement group_id="B6" value="16"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="32"/>
                    <measurement group_id="B9" value="273"/>
                  </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="1"/>
                    <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_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="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="5"/>
                  </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="1"/>
                    <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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="28"/>
                    <measurement group_id="B6" value="16"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="31"/>
                    <measurement group_id="B9" value="269"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <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="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="45"/>
                    <measurement group_id="B5" value="25"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="26"/>
                    <measurement group_id="B9" value="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Immunestatus</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Seropositive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Seronegative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="24"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="24"/>
                    <measurement group_id="B9" value="229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination</title>
        <description>Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event.</description>
        <time_frame>Up to 24 hours after vaccination on Day 1</time_frame>
        <population>Only participants with available data were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination</title>
          <description>Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event.</description>
          <population>Only participants with available data were used for this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Grade 3 Adverse Reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination</title>
        <description>Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event.</description>
        <time_frame>Up to 60 hours after vaccination on Day 1</time_frame>
        <population>Only participants with available data were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination</title>
          <description>Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event.</description>
          <population>Only participants with available data were used for this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Grade 3 Adverse Reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Local Adverse Events</title>
        <description>Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards.</description>
        <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36)</time_frame>
        <population>Only participants with available data were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Local Adverse Events</title>
          <description>Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards.</description>
          <population>Only participants with available data were used for this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="41"/>
                    <measurement group_id="O5" value="26"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale</title>
        <description>Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.</description>
        <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
        <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of grade 1, 2, and 3 events in the entire analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were be given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale</title>
          <description>Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.</description>
          <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of grade 1, 2, and 3 events in the entire analysis set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="32"/>
                    <measurement group_id="O4" value="29"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="12"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Duration of Solicited Local Adverse Events</title>
        <description>Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.</description>
        <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
        <population>Only participants who experienced solicited local AEs were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Solicited Local Adverse Events</title>
          <description>Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.</description>
          <population>Only participants who experienced solicited local AEs were used for this analysis.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="41"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="11"/>
                <count group_id="O8" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.99"/>
                    <measurement group_id="O2" value="2.0" spread="0.84"/>
                    <measurement group_id="O3" value="2.3" spread="1.02"/>
                    <measurement group_id="O4" value="2.4" spread="1.44"/>
                    <measurement group_id="O5" value="2.6" spread="1.44"/>
                    <measurement group_id="O6" value="2.5" spread="0.82"/>
                    <measurement group_id="O7" value="3.0" spread="1.18"/>
                    <measurement group_id="O8" value="1.2" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Systemic Adverse Events</title>
        <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards.</description>
        <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
        <population>Only participants with available data were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Systemic Adverse Events</title>
          <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards.</description>
          <population>Only participants with available data were used for this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="44"/>
                    <measurement group_id="O4" value="45"/>
                    <measurement group_id="O5" value="28"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale</title>
        <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.</description>
        <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
        <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of grade 1, 2, and 3 events in the entire analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale</title>
          <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.</description>
          <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of grade 1, 2, and 3 events in the entire analysis set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Duration of Solicited Systemic Adverse Events</title>
        <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.</description>
        <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
        <population>Only participants who experienced solicited systemic AEs were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Solicited Systemic Adverse Events</title>
          <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.</description>
          <population>Only participants who experienced solicited systemic AEs were used for this analysis.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="5.38"/>
                    <measurement group_id="O2" value="2.1" spread="1.15"/>
                    <measurement group_id="O3" value="2.4" spread="2.16"/>
                    <measurement group_id="O4" value="3.2" spread="2.40"/>
                    <measurement group_id="O5" value="3.6" spread="1.73"/>
                    <measurement group_id="O6" value="2.5" spread="0.73"/>
                    <measurement group_id="O7" value="3.4" spread="1.24"/>
                    <measurement group_id="O8" value="1.8" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine</title>
        <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.</description>
        <time_frame>Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)</time_frame>
        <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with solicited adverse events considered related to trial vaccine in the entire analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine</title>
          <description>Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.</description>
          <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with solicited adverse events considered related to trial vaccine in the entire analysis set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="44"/>
                    <measurement group_id="O4" value="44"/>
                    <measurement group_id="O5" value="28"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited Adverse Events</title>
        <description>Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit.</description>
        <time_frame>Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)</time_frame>
        <population>Only participants with available data were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited Adverse Events</title>
          <description>Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit.</description>
          <population>Only participants with available data were used for this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="31"/>
                    <measurement group_id="O5" value="23"/>
                    <measurement group_id="O6" value="13"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Intensity of Unsolicited Adverse Events Assessed by the Investigator</title>
        <description>Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:&#xD;
Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.&#xD;
Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities.&#xD;
Severe: an event that prevented normal everyday activities.</description>
        <time_frame>Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)</time_frame>
        <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of mild, moderate, and severe adverse events in the entire analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated. CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated. CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated. CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated. CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated. CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated. CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated. CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Unsolicited Adverse Events Assessed by the Investigator</title>
          <description>Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:&#xD;
Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.&#xD;
Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities.&#xD;
Severe: an event that prevented normal everyday activities.</description>
          <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of mild, moderate, and severe adverse events in the entire analysis set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="17"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine</title>
        <description>Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.</description>
        <time_frame>Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)</time_frame>
        <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with unsolicited adverse events considered related to trial vaccine in the entire analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8,12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine</title>
          <description>Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.</description>
          <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with unsolicited adverse events considered related to trial vaccine in the entire analysis set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One or More Serious Adverse Events (SAEs)</title>
        <description>An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event.</description>
        <time_frame>Baseline to Day 393</time_frame>
        <population>Only participants with available data were used in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Serious Adverse Events (SAEs)</title>
          <description>An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event.</description>
          <population>Only participants with available data were used in this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine</title>
        <description>An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.</description>
        <time_frame>Baseline to Day 393</time_frame>
        <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with one or more SAEs considered related to trial vaccine in the entire analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine</title>
          <description>An SAE was defined as any untoward medical occurrence that, at any dose:&#xD;
Resulted in death.&#xD;
Was life-threatening.&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Resulted in persistent disability/incapacity.&#xD;
Was a congenital anomaly/birth defect in the offspring of the participant.&#xD;
Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.</description>
          <population>Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with one or more SAEs considered related to trial vaccine in the entire analysis set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One or More Adverse Events of Special Interest (AESIs)</title>
        <description>The following events will be considered as AESIs: adverse events with a suspected immune-mediated etiology, COVID-19 disease and other adverse events relevant to SARS-CoV vaccine development or the target disease.</description>
        <time_frame>Day 1 to Day 393</time_frame>
        <population>Only participants with available data were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Adverse Events of Special Interest (AESIs)</title>
          <description>The following events will be considered as AESIs: adverse events with a suspected immune-mediated etiology, COVID-19 disease and other adverse events relevant to SARS-CoV vaccine development or the target disease.</description>
          <population>Only participants with available data were used for this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies</title>
        <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline.</description>
        <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
        <population>Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies</title>
          <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline.</description>
          <population>Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="12"/>
                  </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="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="44"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="28"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="11"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="8"/>
                  </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="45"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="29"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="15"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="39"/>
                    <measurement group_id="O5" value="27"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="43"/>
                    <measurement group_id="O4" value="44"/>
                    <measurement group_id="O5" value="26"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="12"/>
                  </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="42"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="47"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="43"/>
                    <measurement group_id="O5" value="24"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="34"/>
                    <measurement group_id="O5" value="26"/>
                    <measurement group_id="O6" value="15"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="44"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="27"/>
                    <measurement group_id="O5" value="24"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies</title>
        <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA).</description>
        <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
        <population>The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies</title>
          <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA).</description>
          <population>The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.</population>
          <units>titers</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="12"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.655" spread="3.2545"/>
                    <measurement group_id="O2" value="147.911" spread="3.9771"/>
                    <measurement group_id="O3" value="236.879" spread="3.7524"/>
                    <measurement group_id="O4" value="126.603" spread="2.9179"/>
                    <measurement group_id="O5" value="154.168" spread="5.4433"/>
                    <measurement group_id="O6" value="75.715" spread="1.8549"/>
                    <measurement group_id="O7" value="251.617" spread="6.1263"/>
                    <measurement group_id="O8" value="157.993" spread="4.5998"/>
                  </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="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="33"/>
                    <count group_id="O4" value="31"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="12"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171.645" spread="2.8681"/>
                    <measurement group_id="O2" value="174.350" spread="3.5613"/>
                    <measurement group_id="O3" value="265.287" spread="3.6827"/>
                    <measurement group_id="O4" value="191.152" spread="2.4129"/>
                    <measurement group_id="O5" value="288.123" spread="6.6294"/>
                    <measurement group_id="O6" value="134.706" spread="2.8976"/>
                    <measurement group_id="O7" value="310.262" spread="6.7709"/>
                    <measurement group_id="O8" value="130.610" spread="4.3417"/>
                  </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="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173.625" spread="2.7202"/>
                    <measurement group_id="O2" value="216.617" spread="3.7230"/>
                    <measurement group_id="O3" value="284.084" spread="3.0997"/>
                    <measurement group_id="O4" value="210.045" spread="2.6297"/>
                    <measurement group_id="O5" value="253.696" spread="3.8848"/>
                    <measurement group_id="O6" value="415.167" spread="2.3220"/>
                    <measurement group_id="O7" value="497.175" spread="4.5434"/>
                    <measurement group_id="O8" value="129.860" spread="3.9097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="34"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="664.889" spread="2.9730"/>
                    <measurement group_id="O2" value="1700.053" spread="2.8334"/>
                    <measurement group_id="O3" value="1111.904" spread="2.8305"/>
                    <measurement group_id="O4" value="1254.241" spread="2.9320"/>
                    <measurement group_id="O5" value="1617.127" spread="3.2917"/>
                    <measurement group_id="O6" value="1163.062" spread="2.3845"/>
                    <measurement group_id="O7" value="1837.995" spread="3.4748"/>
                    <measurement group_id="O8" value="192.185" spread="3.8983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="36"/>
                    <count group_id="O4" value="34"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1627.741" spread="2.6501"/>
                    <measurement group_id="O2" value="2375.689" spread="2.3220"/>
                    <measurement group_id="O3" value="2721.933" spread="2.7489"/>
                    <measurement group_id="O4" value="3052.067" spread="2.1718"/>
                    <measurement group_id="O5" value="3955.571" spread="3.3468"/>
                    <measurement group_id="O6" value="1815.393" spread="2.2767"/>
                    <measurement group_id="O7" value="6128.616" spread="2.8347"/>
                    <measurement group_id="O8" value="111.508" spread="3.9442"/>
                  </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="33"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="36"/>
                    <count group_id="O4" value="34"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1013.096" spread="2.8774"/>
                    <measurement group_id="O2" value="1845.542" spread="2.6503"/>
                    <measurement group_id="O3" value="1402.290" spread="2.3704"/>
                    <measurement group_id="O4" value="1591.849" spread="2.3855"/>
                    <measurement group_id="O5" value="2008.570" spread="2.6719"/>
                    <measurement group_id="O6" value="807.740" spread="2.2712"/>
                    <measurement group_id="O7" value="4793.501" spread="2.8151"/>
                    <measurement group_id="O8" value="108.232" spread="3.7280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="33"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="301.870" spread="4.3641"/>
                    <measurement group_id="O2" value="792.188" spread="2.2970"/>
                    <measurement group_id="O3" value="421.869" spread="3.3192"/>
                    <measurement group_id="O4" value="360.492" spread="2.4772"/>
                    <measurement group_id="O5" value="807.498" spread="2.9110"/>
                    <measurement group_id="O6" value="687.391" spread="3.4095"/>
                    <measurement group_id="O7" value="1100.769" spread="2.7710"/>
                    <measurement group_id="O8" value="99.688" spread="2.9239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="33"/>
                    <count group_id="O4" value="31"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="195.059" spread="3.0680"/>
                    <measurement group_id="O2" value="330.530" spread="2.8422"/>
                    <measurement group_id="O3" value="317.495" spread="4.2611"/>
                    <measurement group_id="O4" value="175.809" spread="2.3936"/>
                    <measurement group_id="O5" value="623.730" spread="2.8041"/>
                    <measurement group_id="O6" value="408.985" spread="2.0742"/>
                    <measurement group_id="O7" value="1027.909" spread="4.3847"/>
                    <measurement group_id="O8" value="84.518" spread="2.8642"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies</title>
        <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline.</description>
        <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
        <population>Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies</title>
          <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline.</description>
          <population>Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="7"/>
                  </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="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="44"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="5"/>
                  </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="45"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="6"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="34"/>
                    <measurement group_id="O5" value="21"/>
                    <measurement group_id="O6" value="14"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="43"/>
                    <measurement group_id="O5" value="26"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="2"/>
                  </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="42"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="49"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="33"/>
                    <measurement group_id="O4" value="40"/>
                    <measurement group_id="O5" value="23"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="34"/>
                    <measurement group_id="O5" value="20"/>
                    <measurement group_id="O6" value="13"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="44"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="17"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="9"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies</title>
        <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA).</description>
        <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
        <population>The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies</title>
          <description>Measured using Enzyme-Linked Immunosorbent Assay (ELISA).</description>
          <population>The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.</population>
          <units>titers</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="12"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.000" spread="1.0000"/>
                    <measurement group_id="O2" value="50.000" spread="1.0000"/>
                    <measurement group_id="O3" value="50.000" spread="1.0000"/>
                    <measurement group_id="O4" value="58.735" spread="1.5490"/>
                    <measurement group_id="O5" value="50.000" spread="1.0000"/>
                    <measurement group_id="O6" value="69.659" spread="2.9999"/>
                    <measurement group_id="O7" value="72.203" spread="3.5712"/>
                    <measurement group_id="O8" value="54.509" spread="1.3290"/>
                  </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="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="33"/>
                    <count group_id="O4" value="31"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="12"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.000" spread="1.0000"/>
                    <measurement group_id="O2" value="50.000" spread="1.0000"/>
                    <measurement group_id="O3" value="55.894" spread="1.6444"/>
                    <measurement group_id="O4" value="53.520" spread="1.3017"/>
                    <measurement group_id="O5" value="50.000" spread="1.0000"/>
                    <measurement group_id="O6" value="68.942" spread="3.0430"/>
                    <measurement group_id="O7" value="74.942" spread="4.0629"/>
                    <measurement group_id="O8" value="52.644" spread="1.2734"/>
                  </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="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.515" spread="1.1962"/>
                    <measurement group_id="O2" value="55.237" spread="1.4574"/>
                    <measurement group_id="O3" value="53.447" spread="1.5000"/>
                    <measurement group_id="O4" value="52.773" spread="1.2523"/>
                    <measurement group_id="O5" value="60.458" spread="1.5674"/>
                    <measurement group_id="O6" value="74.346" spread="2.7022"/>
                    <measurement group_id="O7" value="89.597" spread="4.1779"/>
                    <measurement group_id="O8" value="50.000" spread="1.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="34"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.943" spread="2.4539"/>
                    <measurement group_id="O2" value="201.936" spread="4.2892"/>
                    <measurement group_id="O3" value="144.011" spread="3.1421"/>
                    <measurement group_id="O4" value="255.615" spread="3.5880"/>
                    <measurement group_id="O5" value="351.489" spread="4.7386"/>
                    <measurement group_id="O6" value="321.393" spread="3.2174"/>
                    <measurement group_id="O7" value="388.660" spread="6.5376"/>
                    <measurement group_id="O8" value="54.303" spread="1.4598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="36"/>
                    <count group_id="O4" value="34"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="215.648" spread="3.3361"/>
                    <measurement group_id="O2" value="510.141" spread="4.0840"/>
                    <measurement group_id="O3" value="418.085" spread="3.9185"/>
                    <measurement group_id="O4" value="884.327" spread="3.5980"/>
                    <measurement group_id="O5" value="1401.175" spread="3.7419"/>
                    <measurement group_id="O6" value="1280.261" spread="2.6560"/>
                    <measurement group_id="O7" value="2035.914" spread="3.3154"/>
                    <measurement group_id="O8" value="54.694" spread="1.4938"/>
                  </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="33"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="36"/>
                    <count group_id="O4" value="34"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122.337" spread="3.0011"/>
                    <measurement group_id="O2" value="215.011" spread="3.5638"/>
                    <measurement group_id="O3" value="237.379" spread="3.7169"/>
                    <measurement group_id="O4" value="532.756" spread="3.3394"/>
                    <measurement group_id="O5" value="739.659" spread="3.9186"/>
                    <measurement group_id="O6" value="948.298" spread="2.7761"/>
                    <measurement group_id="O7" value="1516.255" spread="3.7810"/>
                    <measurement group_id="O8" value="50.000" spread="1.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="33"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.466" spread="1.7283"/>
                    <measurement group_id="O2" value="97.041" spread="2.5246"/>
                    <measurement group_id="O3" value="126.160" spread="3.6256"/>
                    <measurement group_id="O4" value="161.237" spread="2.5113"/>
                    <measurement group_id="O5" value="222.516" spread="3.4086"/>
                    <measurement group_id="O6" value="231.544" spread="2.8738"/>
                    <measurement group_id="O7" value="551.059" spread="3.7490"/>
                    <measurement group_id="O8" value="50.000" spread="1.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="33"/>
                    <count group_id="O4" value="31"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.000" spread="1.0000"/>
                    <measurement group_id="O2" value="73.596" spread="2.2529"/>
                    <measurement group_id="O3" value="102.077" spread="4.2320"/>
                    <measurement group_id="O4" value="70.541" spread="1.9584"/>
                    <measurement group_id="O5" value="208.484" spread="3.7448"/>
                    <measurement group_id="O6" value="139.858" spread="4.1588"/>
                    <measurement group_id="O7" value="390.307" spread="4.9577"/>
                    <measurement group_id="O8" value="50.000" spread="1.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies</title>
        <description>Measured using an activity assay. In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. In participants seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline.</description>
        <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
        <population>Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies</title>
          <description>Measured using an activity assay. In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. In participants seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline.</description>
          <population>Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="28"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="3"/>
                  </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="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="44"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="21"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="4"/>
                  </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="45"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="35"/>
                    <measurement group_id="O5" value="23"/>
                    <measurement group_id="O6" value="12"/>
                    <measurement group_id="O7" value="9"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="36"/>
                    <measurement group_id="O4" value="39"/>
                    <measurement group_id="O5" value="25"/>
                    <measurement group_id="O6" value="15"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="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="42"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="47"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="45"/>
                    <measurement group_id="O5" value="22"/>
                    <measurement group_id="O6" value="14"/>
                    <measurement group_id="O7" value="9"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="28"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="10"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="44"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies</title>
        <description>Measured using an activity assay.</description>
        <time_frame>Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211</time_frame>
        <population>The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation CVnCoV: 2 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation CVnCoV: 4 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation CVnCoV: 6 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation CVnCoV: 8 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation CVnCoV: 12 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O6">
            <title>Dose Escalation CVnCoV: 16 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O7">
            <title>Dose Escalation CVnCoV: 20 µg</title>
            <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29. Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
          <group group_id="O8">
            <title>Dose Escalation Placebo</title>
            <description>Participants were given placebo on Day 1 and Day 29. Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies</title>
          <description>Measured using an activity assay.</description>
          <population>The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.</population>
          <units>titers</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="12"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.000" spread="1.0000"/>
                    <measurement group_id="O2" value="5.000" spread="1.0000"/>
                    <measurement group_id="O3" value="5.000" spread="1.0000"/>
                    <measurement group_id="O4" value="5.221" spread="1.1859"/>
                    <measurement group_id="O5" value="5.000" spread="1.000"/>
                    <measurement group_id="O6" value="5.000" spread="1.0000"/>
                    <measurement group_id="O7" value="8.170" spread="5.4783"/>
                    <measurement group_id="O8" value="5.242" spread="1.2481"/>
                  </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="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="33"/>
                    <count group_id="O4" value="31"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="12"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.000" spread="1.0000"/>
                    <measurement group_id="O2" value="5.000" spread="1.0000"/>
                    <measurement group_id="O3" value="5.106" spread="1.1282"/>
                    <measurement group_id="O4" value="8.269" spread="2.3683"/>
                    <measurement group_id="O5" value="5.000" spread="1.0000"/>
                    <measurement group_id="O6" value="5.000" spread="1.0000"/>
                    <measurement group_id="O7" value="9.715" spread="6.7304"/>
                    <measurement group_id="O8" value="5.000" spread="1.0000"/>
                  </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="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.000" spread="1.0000"/>
                    <measurement group_id="O2" value="5.191" spread="1.2560"/>
                    <measurement group_id="O3" value="5.095" spread="1.1207"/>
                    <measurement group_id="O4" value="8.042" spread="2.3671"/>
                    <measurement group_id="O5" value="5.000" spread="1.0000"/>
                    <measurement group_id="O6" value="5.496" spread="1.3681"/>
                    <measurement group_id="O7" value="10.905" spread="7.3473"/>
                    <measurement group_id="O8" value="5.160" spread="1.1593"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="34"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.240" spread="3.2214"/>
                    <measurement group_id="O2" value="17.340" spread="4.0855"/>
                    <measurement group_id="O3" value="13.577" spread="3.1691"/>
                    <measurement group_id="O4" value="26.336" spread="3.9767"/>
                    <measurement group_id="O5" value="22.224" spread="2.9539"/>
                    <measurement group_id="O6" value="14.142" spread="3.0248"/>
                    <measurement group_id="O7" value="38.860" spread="6.7690"/>
                    <measurement group_id="O8" value="5.430" spread="1.3051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="36"/>
                    <count group_id="O4" value="34"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.664" spread="5.0333"/>
                    <measurement group_id="O2" value="33.813" spread="4.0230"/>
                    <measurement group_id="O3" value="26.696" spread="4.2447"/>
                    <measurement group_id="O4" value="51.086" spread="3.5503"/>
                    <measurement group_id="O5" value="52.462" spread="3.4275"/>
                    <measurement group_id="O6" value="33.108" spread="3.2347"/>
                    <measurement group_id="O7" value="119.865" spread="6.8222"/>
                    <measurement group_id="O8" value="6.050" spread="1.8413"/>
                  </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="33"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="36"/>
                    <count group_id="O4" value="34"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.419" spread="2.9626"/>
                    <measurement group_id="O2" value="11.892" spread="3.2240"/>
                    <measurement group_id="O3" value="13.348" spread="3.0155"/>
                    <measurement group_id="O4" value="49.044" spread="3.1527"/>
                    <measurement group_id="O5" value="24.786" spread="2.9671"/>
                    <measurement group_id="O6" value="28.284" spread="3.0577"/>
                    <measurement group_id="O7" value="96.647" spread="7.8329"/>
                    <measurement group_id="O8" value="5.612" spread="1.4462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="33"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.547" spread="1.6565"/>
                    <measurement group_id="O2" value="7.564" spread="2.0377"/>
                    <measurement group_id="O3" value="8.369" spread="2.2413"/>
                    <measurement group_id="O4" value="11.462" spread="2.2848"/>
                    <measurement group_id="O5" value="14.366" spread="3.1876"/>
                    <measurement group_id="O6" value="20.640" spread="5.0609"/>
                    <measurement group_id="O7" value="49.869" spread="4.5037"/>
                    <measurement group_id="O8" value="5.000" spread="1.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="33"/>
                    <count group_id="O4" value="31"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.001" spread="2.3126"/>
                    <measurement group_id="O2" value="9.247" spread="2.8688"/>
                    <measurement group_id="O3" value="11.107" spread="4.0813"/>
                    <measurement group_id="O4" value="8.086" spread="1.9730"/>
                    <measurement group_id="O5" value="6.234" spread="1.6616"/>
                    <measurement group_id="O6" value="5.325" spread="1.2324"/>
                    <measurement group_id="O7" value="11.487" spread="4.3194"/>
                    <measurement group_id="O8" value="5.000" spread="1.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 up to Day 393</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dose Escalation CVnCoV: 2 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="E2">
          <title>Dose Escalation CVnCoV: 4 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="E3">
          <title>Dose Escalation CVnCoV: 6 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="E4">
          <title>Dose Escalation CVnCoV: 8 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="E5">
          <title>Dose Escalation CVnCoV: 12 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="E6">
          <title>Dose Escalation CVnCoV: 16 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="E7">
          <title>Dose Escalation CVnCoV: 20 µg</title>
          <description>Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.&#xD;
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.&#xD;
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
        <group group_id="E8">
          <title>Dose Escalation Placebo</title>
          <description>Participants were given placebo on Day 1 and Day 29.&#xD;
Placebo: Participants received an intramuscular injection by needle in the deltoid area.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (24.1)</default_vocab>
        <default_assessment>Non-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="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Retinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </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="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Peroneal nerve palsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (24.1)</default_vocab>
        <default_assessment>Non-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="23" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="48"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="25" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="22" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="16"/>
                <counts group_id="E7" subjects_affected="12" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="17" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Macrocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Cardiovascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Gilbert's syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="4" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="5" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection site discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Enterobiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Epstein-Barr virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vitamin B12 deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="47"/>
                <counts group_id="E2" events="13" subjects_affected="7" subjects_at_risk="48"/>
                <counts group_id="E3" events="10" subjects_affected="7" subjects_at_risk="48"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="13" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E8" events="4" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="48"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" events="5" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Taste disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Morton's neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmerorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </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="4" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="6" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Eccymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Neurodermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Information</name_or_title>
      <organization>CureVac AG</organization>
      <phone>+49 6976805870</phone>
      <email>clinicaltrials@curevac.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/NCT04449276
org study id: CV-NCOV-001
secondary id: 2020-001286-36
nct id: NCT04449276
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose
      administrations of CVnCoV at different dose levels.
Funded by Coalition for Epidemic Preparedness Innovations (CEPI).

      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: In the initial part of the dose escalation, participants will be enrolled in sentinel groups in an open manner. In the second part, participants will be enrolled in placebo-controlled groups in an observer-blind manner.
measure: Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination
time frame: Up to 24 hours after vaccination on Day 1
description: Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:
Resulted in death.
Was life-threatening.
Required inpatient hospitalization or prolongation of existing hospitalization.
Resulted in persistent disability/incapacity.
Was a congenital anomaly/birth defect in the offspring of the participant.
Was an important medical event.
measure: Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination
time frame: Up to 60 hours after vaccination on Day 1
description: Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose:
Resulted in death.
Was life-threatening.
Required inpatient hospitalization or prolongation of existing hospitalization.
Resulted in persistent disability/incapacity.
Was a congenital anomaly/birth defect in the offspring of the participant.
Was an important medical event.
measure: Number of Participants With Solicited Local Adverse Events
time frame: Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36)
description: Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards.
measure: Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale
time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
description: Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
measure: Duration of Solicited Local Adverse Events
time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
description: Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
measure: Number of Participants With Solicited Systemic Adverse Events
time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
description: Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards.
measure: Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale
time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
description: Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
measure: Duration of Solicited Systemic Adverse Events
time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
description: Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
measure: Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine
time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
description: Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
measure: Number of Participants With Unsolicited Adverse Events
time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
description: Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit.
measure: Intensity of Unsolicited Adverse Events Assessed by the Investigator
time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
description: Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:
Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.
Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities.
Severe: an event that prevented normal everyday activities.
measure: Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine
time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
description: Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
measure: Number of Participants With One or More Serious Adverse Events (SAEs)
time frame: Baseline to Day 393
description: An SAE was defined as any untoward medical occurrence that, at any dose:
Resulted in death.
Was life-threatening.
Required inpatient hospitalization or prolongation of existing hospitalization.
Resulted in persistent disability/incapacity.
Was a congenital anomaly/birth defect in the offspring of the participant.
Was an important medical event.
measure: Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine
time frame: Baseline to Day 393
description: An SAE was defined as any untoward medical occurrence that, at any dose:
Resulted in death.
Was life-threatening.
Required inpatient hospitalization or prolongation of existing hospitalization.
Resulted in persistent disability/incapacity.
Was a congenital anomaly/birth defect in the offspring of the participant.
Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
measure: Number of Participants With One or More Adverse Events of Special Interest (AESIs)
time frame: Day 1 to Day 393
description: The following events will be considered as AESIs: adverse events with a suspected immune-mediated etiology, COVID-19 disease and other adverse events relevant to SARS-CoV vaccine development or the target disease.
measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline.
measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline.
measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
description: Measured using an activity assay. In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. In participants seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline.
measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
time frame: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211
description: Measured using an activity assay.
arm group label: Dose Escalation CVnCoV
arm group type: Experimental
description: Participants will be vaccinated with CVnCoV at escalating dose levels on Day 1 and Day 29. Safety data will inform the decision to continue enrolling at the current dose level, or to proceed to dose escalation. Initially, dose levels of 2, 4 and 8 μg will be evaluated.
Dose levels of 2, 4, 6, 8 and 12µg will be evaluated with potential increase to dose levels up to 20 μg.
arm group label: Dose Escalation Placebo
arm group type: Placebo Comparator
description: Participants will be given placebo on Day 1 and Day 29.
intervention type: Biological
intervention name: CVnCoV Vaccine
description: Participants will receive an intramuscular injection by needle in the deltoid area.
arm group label: Dose Escalation CVnCoV
other name: CV07050101
intervention type: Drug
intervention name: Placebo
description: Participants will receive an intramuscular injection by needle in the deltoid area.
arm group label: Dose Escalation Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Germany
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Severe Acute Respiratory Syndrome
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 