<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/NCT01668537</url>
  </required_header>
  <id_info>
    <org_study_id>POX-MVA-027</org_study_id>
    <nct_id>NCT01668537</nct_id>
  </id_info>
  <brief_title>A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects</brief_title>
  <official_title>A Randomized, Double-blind, Multicenter Phase II Trial to Compare the Immunogenicity and Safety of a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bavarian Nordic</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bavarian Nordic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and&#xD;
      safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox&#xD;
      vaccine in vaccinia-naïve healthy subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ELISA GMT</measure>
    <time_frame>Week 6</time_frame>
    <description>Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events</measure>
    <time_frame>up to 32 weeks</time_frame>
    <description>Occurrence, relationship to the trial vaccine and intensity of any Serious Adverse Event (SAE).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events of Special Interest (AESI)</measure>
    <time_frame>up to 32 weeks</time_frame>
    <description>Occurrence, relationship to the trial vaccine and intensity of any Adverse Event of Special Interest (AESI). AESIs were defined as any cardiac symptoms and ECG changes determined to be clinically significant or cardiac enzyme troponin I elevated above 2 x the Upper Limit of Normal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Related Grade &gt;=3 Adverse Events</measure>
    <time_frame>within 29 days after vaccination</time_frame>
    <description>Occurrence of any Grade &gt;=3 Adverse Events related to the trial vaccine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Unsolicited Adverse Events</measure>
    <time_frame>within 29 days after vaccination</time_frame>
    <description>Occurrence, relationship to the trial vaccine and intensity of unsolicited treatment-emergent AEs (TEAEs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Solicited Local Averse Events</measure>
    <time_frame>8 days after any vaccination</time_frame>
    <description>Occurrence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Solicited General Adverse Events</measure>
    <time_frame>within 8 days after any vaccination</time_frame>
    <description>Occurrence, intensity and relationship to the trial vaccines of solicited general AEs (pyrexia, headache, myalgia, nausea, fatigue and chills) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELISA GMTs</measure>
    <time_frame>within 8 weeks</time_frame>
    <description>Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values &lt;DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PRNT GMT</measure>
    <time_frame>Week 6</time_frame>
    <description>Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PRNT GMTs</measure>
    <time_frame>within 8 weeks</time_frame>
    <description>Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values &lt;DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroconversion by ELISA</measure>
    <time_frame>Week 6</time_frame>
    <description>Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroconversion by ELISA</measure>
    <time_frame>within 8 weeks</time_frame>
    <description>Seroconversion rates at all post-baseline immunogenicity sampling time points based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroconversion by PRNT</measure>
    <time_frame>Week 6</time_frame>
    <description>Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroconversion by PRNT</measure>
    <time_frame>within 8 weeks</time_frame>
    <description>Seroconversion rates at all post-baseline immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELISPOT Magnitudes of Response</measure>
    <time_frame>within 8 weeks</time_frame>
    <description>Magnitudes of response of IFNγ producing T-cells measured by vaccinica-specific ELISPOT. Spot Forming Units below the detection limit are included as a value of '1'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Response by ELISPOT</measure>
    <time_frame>within 8 weeks</time_frame>
    <description>Response rates regarding IFNγ producing T-cells measured by vaccinia-specific ELISPOT. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders by ELISPOT</measure>
    <time_frame>within 8 weeks</time_frame>
    <description>Responder rate measured by vaccinia specific ELISPOT. A participant was defined as a responder to the vaccine determined by ELISPOT if the participant had at least 1 post-baseline visit determined to be a response. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation ELISA vs PRNT Titers</measure>
    <time_frame>within 8 weeks</time_frame>
    <description>Pearson Correlation Coefficient between the ELISA titers and the PRNT titers at weeks 4, 6 and 8 based on the log10 transformed titer values</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">651</enrollment>
  <condition>Smallpox</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LF formulation of IMVAMUNE® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FD formulation of IMVAMUNE® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>LF formulation of IMVAMUNE®</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FD formulation of IMVAMUNE®</intervention_name>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Male and female subjects, 18-55 years of age&#xD;
&#xD;
          2. The subject has read, signed and dated informed consent form, having been advised of&#xD;
             the risks and benefits of the trial in a language understood by the subject and prior&#xD;
             to performance of any trial specific procedures and has signed the Health Insurance&#xD;
             Portability and Accountability Act (HIPAA) authorization form&#xD;
&#xD;
          3. Body Mass Index (BMI) ≥ 18.5 and &lt; 35&#xD;
&#xD;
          4. Women of childbearing potential (WOCBP) must have used an acceptable method of&#xD;
             contraception for 30 days prior to the first vaccination, must agree to use an&#xD;
             acceptable method of contraception during the trial, and must avoid becoming pregnant&#xD;
             for at least 28 days after the last vaccination. A woman is considered of childbearing&#xD;
             potential unless post-menopausal or with a history of hysterectomy. (Acceptable&#xD;
             contraception methods are restricted to abstinence, barrier contraceptives,&#xD;
             intrauterine contraceptive devices or licensed hormonal products)&#xD;
&#xD;
          5. WOCBP must have a negative serum pregnancy test at screening (SCR) and a negative&#xD;
             urine pregnancy test within 24 hours prior to each vaccination&#xD;
&#xD;
          6. White blood cells ≥ 2500/mm3 and &lt; ULN&#xD;
&#xD;
          7. Absolute neutrophil count (ANC) within normal limits&#xD;
&#xD;
          8. Hemoglobin within normal limits&#xD;
&#xD;
          9. Platelets within normal limits&#xD;
&#xD;
         10. Adequate renal function defined as a calculated Creatinine Clearance (CrCl) &gt; 60&#xD;
             ml/min as estimated by the Cockcroft-Gault equation:&#xD;
&#xD;
               -  For men: (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dl&#xD;
                  x 72) = CrCl (ml/min)&#xD;
&#xD;
               -  For women: multiply the result by 0.85 = CrCl (ml/min)&#xD;
&#xD;
         11. Adequate hepatic function defined as:&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN) in the absence of other&#xD;
                  evidence of significant liver disease&#xD;
&#xD;
               -  Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline&#xD;
                  phosphatase &lt; 1.5 x ULN&#xD;
&#xD;
         12. Troponin I &lt; 2 x ULN&#xD;
&#xD;
         13. Electrocardiogram (ECG) without clinically significant findings, e.g. any kind of&#xD;
             atrioventricular or intraventricular conditions or blocks such as complete left or&#xD;
             right bundle branch block, AV node block, QTc or PR prolongation, premature atrial&#xD;
             contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two&#xD;
             premature ventricular contractions (PVC) in a row, ST elevation consistent with&#xD;
             ischemia&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Typical vaccinia scar&#xD;
&#xD;
          2. Known or suspected history of smallpox vaccination&#xD;
&#xD;
          3. History of vaccination with any poxvirus-based vaccine&#xD;
&#xD;
          4. US Military service before 1991 or after January 2003&#xD;
&#xD;
          5. Pregnant or breast-feeding women&#xD;
&#xD;
          6. Uncontrolled serious infection, i.e. not responding to antimicrobial therapy&#xD;
&#xD;
          7. History of any serious medical condition, which in the opinion of the investigator&#xD;
             would compromise the safety of the subject or would limit the subject's ability to&#xD;
             complete the trial in the opinion of the investigator&#xD;
&#xD;
          8. History of or active autoimmune disease, persons with vitiligo or thyroid disease&#xD;
             taking thyroid hormone replacement are not excluded&#xD;
&#xD;
          9. Known or suspected impairment of immunologic function including, but not limited to,&#xD;
             clinically significant liver disease, diabetes mellitus, moderate to severe kidney&#xD;
             impairment&#xD;
&#xD;
         10. History of malignancy, other than squamous cell or basal cell skin cancer, unless&#xD;
             there has been surgical excision that is considered to have achieved cure. Subjects&#xD;
             with history of skin cancer must not be vaccinated at the previous tumor site&#xD;
&#xD;
         11. History or clinical manifestation of clinically significant and severe hematological,&#xD;
             pulmonary, central nervous, cardiovascular or gastrointestinal disorders&#xD;
&#xD;
         12. Clinically significant mental disorder not adequately controlled by medical treatment&#xD;
&#xD;
         13. History of coronary heart disease, myocardial infarction, angina, congestive heart&#xD;
             failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood&#xD;
             pressure, or any other heart condition under the care of a doctor&#xD;
&#xD;
         14. History of an immediate family member (father, mother, brother, or sister) who has had&#xD;
             onset of ischemic heart disease before the age of 50 years&#xD;
&#xD;
         15. Twenty percent or greater risk of developing a myocardial infarction or coronary death&#xD;
             within the next 10 years using the National Cholesterol Education Program's Risk&#xD;
             Assessment Tool: http://hin.nhlbi.nih.gov/atpiii/calculator.asp NOTE: This criterion&#xD;
             applies only to subjects 20 years of age and older&#xD;
&#xD;
         16. Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse&#xD;
             (within the past 6 months)&#xD;
&#xD;
         17. Known allergy to IMVAMUNE® vaccine and its constituents, e.g.&#xD;
             tris(hydroxymethyl)-amino methane, including known allergy to egg or aminoglycoside&#xD;
             (gentamycin)&#xD;
&#xD;
         18. History of anaphylaxis or severe allergic reaction to any vaccine&#xD;
&#xD;
         19. Acute disease (illness with or without a fever) at the time of enrollment&#xD;
&#xD;
         20. Body Temperature ≥ 100.4°F (38.0°C) at the time of enrollment&#xD;
&#xD;
         21. Having received any vaccinations or planned vaccinations with a live vaccine within 30&#xD;
             days prior or after trial vaccination&#xD;
&#xD;
         22. Having received any vaccinations or planned vaccinations with a killed vaccine within&#xD;
             14 days prior or after trial vaccination&#xD;
&#xD;
         23. Chronic systemic administration (defined as more than 14 days) of &gt; 5 mg prednisone&#xD;
             (or equivalent)/day or any other immune-modifying drugs during a period starting from&#xD;
             three months prior to administration of the vaccine and ending at last physical trial&#xD;
             visit (Visit 5)&#xD;
&#xD;
         24. Post organ transplant subjects whether or not receiving chronic immunosuppressive&#xD;
             therapy&#xD;
&#xD;
         25. Administration or planned administration of immunoglobulins and/or any blood products&#xD;
             during a period starting from three months prior to administration of the vaccine and&#xD;
             ending at last physical trial visit (Visit 5)&#xD;
&#xD;
         26. Use of any investigational or non-registered drug or vaccine other than the trial&#xD;
             vaccine within 30 days preceding the first dose of the trial vaccine or planned&#xD;
             administration of such a drug during the trial period (with the day of the FU call&#xD;
             being considered the last day of the trial period).&#xD;
&#xD;
         27. Trial personnel&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard N Greenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miami Research Associates</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRA</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <results_first_submitted>September 15, 2020</results_first_submitted>
  <results_first_submitted_qc>October 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2020</results_first_posted>
  <last_update_submitted>October 9, 2020</last_update_submitted>
  <last_update_submitted_qc>October 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccinia</mesh_term>
    <mesh_term>Smallpox</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>LF Formulation</title>
          <description>Liquid Frozen (LF) formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, subcutaneous (s.c.), 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
        </group>
        <group group_id="P2">
          <title>FD Formulation</title>
          <description>Freeze Dried (FD) formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="327"/>
                <participants group_id="P2" count="324"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="305"/>
                <participants group_id="P2" count="314"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Request to Discontinue Prematurely</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject unwilling/unable to comply</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Precludes Participation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set</population>
      <group_list>
        <group group_id="B1">
          <title>LF Formulation</title>
          <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
        </group>
        <group group_id="B2">
          <title>FD Formulation</title>
          <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
        </group>
        <group group_id="B3">
          <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="327"/>
            <count group_id="B2" value="324"/>
            <count group_id="B3" value="651"/>
          </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="27.8" spread="6.36"/>
                    <measurement group_id="B2" value="27.6" spread="6.21"/>
                    <measurement group_id="B3" value="27.7" spread="6.28"/>
                  </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="178"/>
                    <measurement group_id="B2" value="170"/>
                    <measurement group_id="B3" value="348"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="154"/>
                    <measurement group_id="B3" value="303"/>
                  </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="95"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="190"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="232"/>
                    <measurement group_id="B2" value="229"/>
                    <measurement group_id="B3" value="461"/>
                  </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_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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="239"/>
                    <measurement group_id="B2" value="247"/>
                    <measurement group_id="B3" value="486"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="327"/>
                    <measurement group_id="B2" value="324"/>
                    <measurement group_id="B3" value="651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>ELISA GMT</title>
        <description>Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'</description>
        <time_frame>Week 6</time_frame>
        <population>Per Protocol Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMT</title>
          <description>Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'</description>
          <population>Per Protocol Analysis Set</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="306"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="875.1" lower_limit="801.3" upper_limit="955.7"/>
                    <measurement group_id="O2" value="1099.6" lower_limit="1014.8" upper_limit="1191.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority margin to show that the FD formulation is non-inferior to the LF formulation in terms of ELISA GMTs at the peak visit (Week 6) was predefined as '1.5' for the GMT ratio (LF/FD). Non-inferiority is demonstrated if the upper 95% CI of the GMT ratio (LF/FD) is entirely below 1.5</non_inferiority_desc>
            <param_type>GMT ratio (LF/FD)</param_type>
            <param_value>0.796</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.707</ci_lower_limit>
            <ci_upper_limit>0.896</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events</title>
        <description>Occurrence, relationship to the trial vaccine and intensity of any Serious Adverse Event (SAE).</description>
        <time_frame>up to 32 weeks</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events</title>
          <description>Occurrence, relationship to the trial vaccine and intensity of any Serious Adverse Event (SAE).</description>
          <population>Full 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="327"/>
                <count group_id="O2" value="324"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE related to vaccine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE Grade &gt;=3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events of Special Interest (AESI)</title>
        <description>Occurrence, relationship to the trial vaccine and intensity of any Adverse Event of Special Interest (AESI). AESIs were defined as any cardiac symptoms and ECG changes determined to be clinically significant or cardiac enzyme troponin I elevated above 2 x the Upper Limit of Normal</description>
        <time_frame>up to 32 weeks</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events of Special Interest (AESI)</title>
          <description>Occurrence, relationship to the trial vaccine and intensity of any Adverse Event of Special Interest (AESI). AESIs were defined as any cardiac symptoms and ECG changes determined to be clinically significant or cardiac enzyme troponin I elevated above 2 x the Upper Limit of Normal</description>
          <population>Full 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="327"/>
                <count group_id="O2" value="324"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AESI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related AESI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESI Grade &gt;=3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Related Grade &gt;=3 Adverse Events</title>
        <description>Occurrence of any Grade &gt;=3 Adverse Events related to the trial vaccine.</description>
        <time_frame>within 29 days after vaccination</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Related Grade &gt;=3 Adverse Events</title>
          <description>Occurrence of any Grade &gt;=3 Adverse Events related to the trial vaccine.</description>
          <population>Full 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="327"/>
                <count group_id="O2" value="324"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Unsolicited Adverse Events</title>
        <description>Occurrence, relationship to the trial vaccine and intensity of unsolicited treatment-emergent AEs (TEAEs).</description>
        <time_frame>within 29 days after vaccination</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited Adverse Events</title>
          <description>Occurrence, relationship to the trial vaccine and intensity of unsolicited treatment-emergent AEs (TEAEs).</description>
          <population>Full 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="327"/>
                <count group_id="O2" value="324"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="313"/>
                    <measurement group_id="O2" value="310"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="207"/>
                    <measurement group_id="O2" value="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE Grade &gt;=3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related TEAE Grade &gt;=3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Solicited Local Averse Events</title>
        <description>Occurrence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).</description>
        <time_frame>8 days after any vaccination</time_frame>
        <population>Subjects of the Full Analysis Set with at least one completed diary card</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Local Averse Events</title>
          <description>Occurrence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).</description>
          <population>Subjects of the Full Analysis Set with at least one completed diary card</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="322"/>
                <count group_id="O2" value="321"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection site pain : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="274"/>
                    <measurement group_id="O2" value="290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pain : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138"/>
                    <measurement group_id="O2" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pain : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site erythema : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="247"/>
                    <measurement group_id="O2" value="255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site erythema : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site erythema : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="210"/>
                    <measurement group_id="O2" value="223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site induration : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211"/>
                    <measurement group_id="O2" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site induration : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site induration : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pruritus : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177"/>
                    <measurement group_id="O2" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pruritus : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pruritus : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Solicited General Adverse Events</title>
        <description>Occurrence, intensity and relationship to the trial vaccines of solicited general AEs (pyrexia, headache, myalgia, nausea, fatigue and chills) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).</description>
        <time_frame>within 8 days after any vaccination</time_frame>
        <population>Subjects of the Full Analysis Set with at least one completed diary card</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited General Adverse Events</title>
          <description>Occurrence, intensity and relationship to the trial vaccines of solicited general AEs (pyrexia, headache, myalgia, nausea, fatigue and chills) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).</description>
          <population>Subjects of the Full Analysis Set with at least one completed diary card</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="322"/>
                <count group_id="O2" value="321"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Body Temperature increased : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temperature increased : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temperature increased : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temperature increased : Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temperature increased : Related Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                    <measurement group_id="O2" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache : Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache : Related Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia : Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia : Related Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills : Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills : Related Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea : Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea : Related Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue : All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue : Grade &gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue : Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue : Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue : Related Grade =3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISA GMTs</title>
        <description>Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values &lt;DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.</description>
        <time_frame>within 8 weeks</time_frame>
        <population>Per Protocol Analysis Set. Number Analyzed refers to the number of participants with measurements at the respective sampling time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMTs</title>
          <description>Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values &lt;DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.</description>
          <population>Per Protocol Analysis Set. Number Analyzed refers to the number of participants with measurements at the respective sampling time point.</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="306"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                    <measurement group_id="O2" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.0" lower_limit="44.8" upper_limit="69.9"/>
                    <measurement group_id="O2" value="90.4" lower_limit="75.9" upper_limit="107.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="305"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.6" lower_limit="75.0" upper_limit="107.0"/>
                    <measurement group_id="O2" value="131.3" lower_limit="115.8" upper_limit="148.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="875.1" lower_limit="801.3" upper_limit="955.7"/>
                    <measurement group_id="O2" value="1099.6" lower_limit="1014.8" upper_limit="1191.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="546.4" lower_limit="499.4" upper_limit="597.8"/>
                    <measurement group_id="O2" value="689.0" lower_limit="635.2" upper_limit="747.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PRNT GMT</title>
        <description>Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'</description>
        <time_frame>Week 6</time_frame>
        <population>Per Protocol Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>PRNT GMT</title>
          <description>Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'</description>
          <population>Per Protocol Analysis Set</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="306"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.8" lower_limit="73.0" upper_limit="91.6"/>
                    <measurement group_id="O2" value="101.2" lower_limit="91.0" upper_limit="112.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PRNT GMTs</title>
        <description>Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values &lt;DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.</description>
        <time_frame>within 8 weeks</time_frame>
        <population>Per Protocol Analysis Set. Number Analyzed refers to the number of participants with measurements at the respective sampling time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>PRNT GMTs</title>
          <description>Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values &lt;DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.</description>
          <population>Per Protocol Analysis Set. Number Analyzed refers to the number of participants with measurements at the respective sampling time point.</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="306"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="6.0" upper_limit="8.6"/>
                    <measurement group_id="O2" value="10.4" lower_limit="8.7" upper_limit="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="305"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" lower_limit="7.9" upper_limit="11.1"/>
                    <measurement group_id="O2" value="12.5" lower_limit="10.6" upper_limit="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.8" lower_limit="73.0" upper_limit="91.6"/>
                    <measurement group_id="O2" value="101.2" lower_limit="91.0" upper_limit="112.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.7" lower_limit="54.0" upper_limit="66.0"/>
                    <measurement group_id="O2" value="76.1" lower_limit="69.6" upper_limit="83.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroconversion by ELISA</title>
        <description>Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects.</description>
        <time_frame>Week 6</time_frame>
        <population>Per Protocol Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion by ELISA</title>
          <description>Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects.</description>
          <population>Per Protocol Analysis Set</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="306"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroconversion by ELISA</title>
        <description>Seroconversion rates at all post-baseline immunogenicity sampling time points based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.</description>
        <time_frame>within 8 weeks</time_frame>
        <population>Per Protocol Analysis Set. Number Analyzed refers to the number of participants with measurements at the respective sampling time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion by ELISA</title>
          <description>Seroconversion rates at all post-baseline immunogenicity sampling time points based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.</description>
          <population>Per Protocol Analysis Set. Number Analyzed refers to the number of participants with measurements at the respective sampling time point.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="306"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.5"/>
                    <measurement group_id="O2" value="91.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="305"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.9"/>
                    <measurement group_id="O2" value="97.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroconversion by PRNT</title>
        <description>Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects.</description>
        <time_frame>Week 6</time_frame>
        <population>Per Protocol Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion by PRNT</title>
          <description>Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects.</description>
          <population>Per Protocol Analysis Set</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="306"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroconversion by PRNT</title>
        <description>Seroconversion rates at all post-baseline immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.</description>
        <time_frame>within 8 weeks</time_frame>
        <population>Per Protocol Analysis Set. Number Analyzed refers to the number of participants with measurements at the respective sampling time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion by PRNT</title>
          <description>Seroconversion rates at all post-baseline immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.</description>
          <population>Per Protocol Analysis Set. Number Analyzed refers to the number of participants with measurements at the respective sampling time point.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="306"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.1"/>
                    <measurement group_id="O2" value="87.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="305"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8"/>
                    <measurement group_id="O2" value="91.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISPOT Magnitudes of Response</title>
        <description>Magnitudes of response of IFNγ producing T-cells measured by vaccinica-specific ELISPOT. Spot Forming Units below the detection limit are included as a value of '1'.</description>
        <time_frame>within 8 weeks</time_frame>
        <population>ELISPOT Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>ELISPOT Magnitudes of Response</title>
          <description>Magnitudes of response of IFNγ producing T-cells measured by vaccinica-specific ELISPOT. Spot Forming Units below the detection limit are included as a value of '1'.</description>
          <population>ELISPOT Analysis Set</population>
          <units>Spot Forming Units</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="393.0" lower_limit="318.0" upper_limit="506.0"/>
                    <measurement group_id="O2" value="581.5" lower_limit="416.0" upper_limit="718.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.0" lower_limit="70.0" upper_limit="107.0"/>
                    <measurement group_id="O2" value="133.0" lower_limit="100.0" upper_limit="170.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="235.0" lower_limit="185.0" upper_limit="343.0"/>
                    <measurement group_id="O2" value="315.0" lower_limit="232.0" upper_limit="412.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.5" lower_limit="115.0" upper_limit="174.0"/>
                    <measurement group_id="O2" value="240.0" lower_limit="146.0" upper_limit="284.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Response by ELISPOT</title>
        <description>Response rates regarding IFNγ producing T-cells measured by vaccinia-specific ELISPOT. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.</description>
        <time_frame>within 8 weeks</time_frame>
        <population>ELISPOT Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Response by ELISPOT</title>
          <description>Response rates regarding IFNγ producing T-cells measured by vaccinia-specific ELISPOT. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.</description>
          <population>ELISPOT Analysis Set</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.0"/>
                    <measurement group_id="O2" value="97.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.0"/>
                    <measurement group_id="O2" value="80.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.0"/>
                    <measurement group_id="O2" value="94.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.0"/>
                    <measurement group_id="O2" value="92.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responders by ELISPOT</title>
        <description>Responder rate measured by vaccinia specific ELISPOT. A participant was defined as a responder to the vaccine determined by ELISPOT if the participant had at least 1 post-baseline visit determined to be a response. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.</description>
        <time_frame>within 8 weeks</time_frame>
        <population>ELISPOT Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders by ELISPOT</title>
          <description>Responder rate measured by vaccinia specific ELISPOT. A participant was defined as a responder to the vaccine determined by ELISPOT if the participant had at least 1 post-baseline visit determined to be a response. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.</description>
          <population>ELISPOT Analysis Set</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation ELISA vs PRNT Titers</title>
        <description>Pearson Correlation Coefficient between the ELISA titers and the PRNT titers at weeks 4, 6 and 8 based on the log10 transformed titer values</description>
        <time_frame>within 8 weeks</time_frame>
        <population>Per Protocol Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LF Formulation</title>
            <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
          </group>
          <group group_id="O2">
            <title>FD Formulation</title>
            <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation ELISA vs PRNT Titers</title>
          <description>Pearson Correlation Coefficient between the ELISA titers and the PRNT titers at weeks 4, 6 and 8 based on the log10 transformed titer values</description>
          <population>Per Protocol Analysis Set</population>
          <units>Pearson Correlation Coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="306"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="305"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.597" lower_limit="0.518" upper_limit="0.665"/>
                    <measurement group_id="O2" value="0.492" lower_limit="0.401" upper_limit="0.572"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.646" lower_limit="0.574" upper_limit="0.708"/>
                    <measurement group_id="O2" value="0.553" lower_limit="0.470" upper_limit="0.627"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.567" lower_limit="0.484" upper_limit="0.640"/>
                    <measurement group_id="O2" value="0.565" lower_limit="0.484" upper_limit="0.637"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>32 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>LF Formulation</title>
          <description>Liquid Frozen formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
LF formulation of MVA-BN®</description>
        </group>
        <group group_id="E2">
          <title>FD Formulation</title>
          <description>Freeze Dried formulation of MVA-BN® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart&#xD;
FD formulation of MVA-BN®</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemolytic Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="327"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Subcutaneous Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="327"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Limb Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="327"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic Ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="327"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="327"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion Spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="327"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="327"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="115" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="114" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" subjects_affected="77" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="324"/>
              </event>
              <event>
                <sub_title>Injection site hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="324"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="324"/>
              </event>
              <event>
                <sub_title>Injection site discoloration</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="324"/>
              </event>
              <event>
                <sub_title>Injection site hematoma</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="324"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="324"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="327"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="324"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Program Lead, Clinical Operations</name_or_title>
      <organization>Bavarian Nordic A/S</organization>
      <phone>+45 3326 ext 8383</phone>
      <email>info@bavarian-nordic.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/NCT01668537
org study id: POX-MVA-027
nct id: NCT01668537
lead sponsor: 
has dmc: Yes
A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and
      safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox
      vaccine in vaccinia-naïve healthy subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: ELISA GMT
time frame: Week 6
description: Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'
measure: Number of Participants With Serious Adverse Events
time frame: up to 32 weeks
description: Occurrence, relationship to the trial vaccine and intensity of any Serious Adverse Event (SAE).
measure: Number of Participants With Adverse Events of Special Interest (AESI)
time frame: up to 32 weeks
description: Occurrence, relationship to the trial vaccine and intensity of any Adverse Event of Special Interest (AESI). AESIs were defined as any cardiac symptoms and ECG changes determined to be clinically significant or cardiac enzyme troponin I elevated above 2 x the Upper Limit of Normal
measure: Number of Participants With Related Grade >=3 Adverse Events
time frame: within 29 days after vaccination
description: Occurrence of any Grade >=3 Adverse Events related to the trial vaccine.
measure: Number of Participants With Unsolicited Adverse Events
time frame: within 29 days after vaccination
description: Occurrence, relationship to the trial vaccine and intensity of unsolicited treatment-emergent AEs (TEAEs).
measure: Number of Participants With Solicited Local Averse Events
time frame: 8 days after any vaccination
description: Occurrence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).
measure: Number of Participants With Solicited General Adverse Events
time frame: within 8 days after any vaccination
description: Occurrence, intensity and relationship to the trial vaccines of solicited general AEs (pyrexia, headache, myalgia, nausea, fatigue and chills) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).
measure: ELISA GMTs
time frame: within 8 weeks
description: Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values <DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.
measure: PRNT GMT
time frame: Week 6
description: Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'
measure: PRNT GMTs
time frame: within 8 weeks
description: Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values <DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.
measure: Percentage of Participants With Seroconversion by ELISA
time frame: Week 6
description: Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects.
measure: Percentage of Participants With Seroconversion by ELISA
time frame: within 8 weeks
description: Seroconversion rates at all post-baseline immunogenicity sampling time points based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
measure: Percentage of Participants With Seroconversion by PRNT
time frame: Week 6
description: Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects.
measure: Percentage of Participants With Seroconversion by PRNT
time frame: within 8 weeks
description: Seroconversion rates at all post-baseline immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
measure: ELISPOT Magnitudes of Response
time frame: within 8 weeks
description: Magnitudes of response of IFNγ producing T-cells measured by vaccinica-specific ELISPOT. Spot Forming Units below the detection limit are included as a value of '1'.
measure: Percentage of Participants With Response by ELISPOT
time frame: within 8 weeks
description: Response rates regarding IFNγ producing T-cells measured by vaccinia-specific ELISPOT. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.
measure: Percentage of Responders by ELISPOT
time frame: within 8 weeks
description: Responder rate measured by vaccinia specific ELISPOT. A participant was defined as a responder to the vaccine determined by ELISPOT if the participant had at least 1 post-baseline visit determined to be a response. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.
measure: Correlation ELISA vs PRNT Titers
time frame: within 8 weeks
description: Pearson Correlation Coefficient between the ELISA titers and the PRNT titers at weeks 4, 6 and 8 based on the log10 transformed titer values
arm group label: Group 1
arm group type: Experimental
description: LF formulation of IMVAMUNE® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart
arm group label: Group 2
arm group type: Experimental
description: FD formulation of IMVAMUNE® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart
intervention type: Biological
intervention name: LF formulation of IMVAMUNE®
arm group label: Group 1
intervention type: Biological
intervention name: FD formulation of IMVAMUNE®
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard N Greenberg, MD
role: Principal Investigator
affiliation: University of Kentucky
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vaccinia
mesh term: Smallpox
mesh term: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 