<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/NCT03769194</url>
  </required_header>
  <id_info>
    <org_study_id>VLA15-201</org_study_id>
    <nct_id>NCT03769194</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study.</brief_title>
  <official_title>Immunogenicity and Safety Study of VLA15, A Multivalent Recombinant OspA (Outer Surface Protein A) Based Vaccine Candidate Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. A Randomized, Controlled, Observer-blind Phase 2 Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study conducted&#xD;
      in two study phases: a run-in phase and a main study phase. The study was investigated 3&#xD;
      doses of a multivalent OspA (Outer Surface Protein A) based Lyme vaccine (VLA15) in healthy&#xD;
      adults aged 18 to 65 years of age. Study participants received 3 immunizations of the vaccine&#xD;
      at a monthly interval. The study assessed the immune response as well as the safety profile&#xD;
      of the vaccine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study.&#xD;
&#xD;
      In the Run-in phase, a total of 120 subjects aged 18 to 40 years were randomized 1:1:1:1 to&#xD;
      receive one of three VLA15 doses (VLA15 low dose (90 µg), VLA15 medium dose (135 µg), VLA15&#xD;
      high dose (180 µg)) or Placebo as intramuscular vaccinations on Days 1, 29 and 57.&#xD;
&#xD;
      Dosing was adjusted by injection volume.&#xD;
&#xD;
      In the Main Study phase, a total of 452 subjects aged 18 to 65 years were randomized 2:2:1 to&#xD;
      receive VLA15 135 µg or VLA15 180 µg, the two dose groups were selected from the Run-in-Phase&#xD;
      or placebo, as intramuscular vaccinations on Days 1, 29 and 57. Subjects were enrolled in two&#xD;
      age groups (18-49 years and 50-65 years) in a ratio of approx. 2:1.&#xD;
&#xD;
      In both study phases, target was to enroll approx. 10 % or more of subjects that were&#xD;
      baseline seropositive for Borrelia burgdorferi sensu latu (Bb s.l.).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">October 2, 2020</completion_date>
  <primary_completion_date type="Actual">December 18, 2019</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>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6</measure>
    <time_frame>at Day 85 / Month 3</time_frame>
    <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>Seroconversion for ELISA is defined as:&#xD;
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a certain time point.&#xD;
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.&#xD;
Percentages are based on the number of subjects with non-missing observations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>GMFR (Geometric Mean of the Fold Rise as compared to baseline) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA.&#xD;
Calculations are based on number of subjects with non-missing results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 18 - 49 years.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 50 - 65 years.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>SCRs (Seroconversion Rate) for Seroconversion for ELISA is defined as:&#xD;
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point.&#xD;
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.&#xD;
Percentages are based on the number of subjects with non-missing observations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>Seroconversion for ELISA is defined as:&#xD;
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point.&#xD;
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.&#xD;
Percentages are based on the number of subjects with non-missing observations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 18 - 49 years.&#xD;
Calculations are based on number of subjects with non-missing results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 50 - 65 years.&#xD;
Calculations are based on number of subjects with non-missing results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SAEs (Serious Adverse Events)</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>Frequency of SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Related SAEs (Serious Adverse Events)</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>Frequency of related SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With AESIs (Adverse Events of Special Interest)</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>Frequency of AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants.&#xD;
AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Related AESIs (Adverse Events of Special Interest)</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>Frequency of related AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants.&#xD;
AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Unsolicited AEs (Adverse Events)</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>Frequency of unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Related Unsolicited AEs (Adverse Events)</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>Frequency of related unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Solicited Local and Solicited Systemic AEs (Adverse Events)</measure>
    <time_frame>Day 1 (day of first vaccination) through Day 7; Day 29 (day of second vaccination) through Day 35; Day 57 (day of third vaccination) through Day 63</time_frame>
    <description>Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after each and after any vaccination; frequency is being assessed in terms of percentage of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 18-49</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), solicited and unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 18-49; frequency is being assessed in terms of percentage of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 50-65 Years</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
    <description>Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 50-65 years; frequency is being assessed in terms of percentage of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End</measure>
    <time_frame>up to Day 365 / Month 12</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">572</enrollment>
  <condition>Lyme Borreliosis</condition>
  <arm_group>
    <arm_group_label>VLA15 low dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VLA15 low dose with Alum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VLA15 medium dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VLA15 medium dose with Alum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VLA15 high dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VLA15 high dose with Alum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VLA15</intervention_name>
    <description>a multivalent recombinant Outer surface protein A (OspA) based vaccine candidate</description>
    <arm_group_label>VLA15 high dose</arm_group_label>
    <arm_group_label>VLA15 low dose</arm_group_label>
    <arm_group_label>VLA15 medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo: PBS (Phosphate Buffered Saline)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Run-in phase:&#xD;
&#xD;
        1. Subject is aged 18 to 40 years at the day of screening (Visit 0);&#xD;
&#xD;
        Main Study phase:&#xD;
&#xD;
          1. Subject is aged18 to 65 years at the day of screening (Visit 0);&#xD;
&#xD;
             Run-in phase and Main Study phase:&#xD;
&#xD;
          2. Subject is of good general health, including subjects with pharmacologically&#xD;
             controlled chronic conditions;&#xD;
&#xD;
          3. Subject has an understanding of the study and its procedures, agrees to its&#xD;
             provisions, and gives written informed consent prior to any study-related procedures;&#xD;
&#xD;
          4. If subject is of childbearing potential:&#xD;
&#xD;
               1. Subject has a negative serum pregnancy test at screening (Visit 0);&#xD;
&#xD;
               2. Subject agrees to employ adequate birth control measures for the duration of the&#xD;
                  study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic&#xD;
             LB (Lyme borreliosis) as suspected or diagnosed by a physician, or received treatment&#xD;
             for LB (Lyme borreliosis) within the last 3 months prior to Visit 0;&#xD;
&#xD;
          2. Subject received previous vaccination against Lyme borreliosis (LB).;&#xD;
&#xD;
          3. Subject had a tick bite within 4 weeks prior to Visit 1;&#xD;
&#xD;
          4. Subject has a medical history of or currently has a clinically relevant disease&#xD;
             (cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk&#xD;
             for participation in the study, based on investigators judgement, such as individuals&#xD;
             with poorly controlled or unstable disease, ongoing suspected or active inflammation,&#xD;
             or poor compliance with pharmacologic treatment. Subjects with pharmacologically&#xD;
             controlled conditions like osteoarthritis, depression, or asthma are eligible;&#xD;
&#xD;
          5. Subject has a medical history of or currently has a neuroinflammatory or autoimmune&#xD;
             disease, including Guillain Barré Syndrome;&#xD;
&#xD;
          6. Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in&#xD;
             the 3 weeks prior to first vaccination or until Day 57 (Visit 3), contraindicating&#xD;
             intramuscular vaccination as judged by the investigator;&#xD;
&#xD;
          7. Subject has received an active or passive immunization within 28 days before first&#xD;
             vaccination at Visit 1 and until Day 85; except for influenza (seasonal or pandemic)&#xD;
             and pneumococcal vaccines which may be administered outside a 7-days interval before&#xD;
             or after any trial vaccination;&#xD;
&#xD;
          8. Subject has received any other non-registered medicinal product in another clinical&#xD;
             trial within 28 days prior to VLA15 vaccination at Visit 1 (Day 1) and throughout the&#xD;
             entire study period or has received a registered medicinal product in another clinical&#xD;
             trial within 28 days prior to VLA15 vaccination at Visit 1 (Day 1) and up to Day 85;&#xD;
&#xD;
          9. Subject has a known or suspected defect of the immune system that would prevent an&#xD;
             immune response to the vaccine, such as subjects with congenital or acquired&#xD;
             immunodeficiency, including infection with human immunodeficiency virus (HIV), status&#xD;
             post organ transplantation or immuno-suppressive therapy within 30 days prior to Visit&#xD;
             1. Immuno-suppressive therapy is defined as administration of chronic (longer than 14&#xD;
             days) prednisone or equivalent 0.05 mg per kg/ per day. Topical and inhaled steroids&#xD;
             are allowed;&#xD;
&#xD;
         10. Subject has a history of anaphylaxis or severe allergic reactions or a known&#xD;
             hypersensitivity or allergic reactions to one of the components of the vaccine;&#xD;
&#xD;
         11. Subject had any malignancy in the past 5 years. If treatment for cancer was&#xD;
             successfully completed more than 5 years ago and the malignancy is considered to be&#xD;
             cured, the subject may be enrolled;&#xD;
&#xD;
         12. Subject had acute febrile infections within 10 days prior to first vaccination;&#xD;
&#xD;
         13. Subject is pregnant (positive serum pregnancy test at screening), has plans to become&#xD;
             pregnant during the course of the study or is lactating at the time of enrollment.&#xD;
             Women of childbearing potential that are unwilling or unable to employ an adequate&#xD;
             birth control measure for the duration of the study.&#xD;
&#xD;
         14. Subject has donated blood or blood-derived products (plasma) within 30 days or&#xD;
             received blood or blood-derived products (plasma) within 90 days prior to first&#xD;
             vaccination in this study or plans to donate or use blood or blood products during the&#xD;
             course of the study;&#xD;
&#xD;
         15. Subject has any condition that, in the opinion of the investigator, may compromise the&#xD;
             subject's well-being, might interfere with evaluation of study endpoints, or would&#xD;
             limit the subject's ability to complete the study;&#xD;
&#xD;
         16. Subject is committed to an institution (by virtue of an order issued either by the&#xD;
             judicial or the administrative authorities);&#xD;
&#xD;
         17. Subject is in a dependent relationship with the sponsor, an investigator or other&#xD;
             study team member, or the study center. Dependent relationships include close&#xD;
             relatives and household members (i.e. children, partner/spouse, siblings, parents) as&#xD;
             well as employees of the investigator or study center personnel.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Consulting, LLC</name>
      <address>
        <city>Milford</city>
        <state>Connecticut</state>
        <zip>06460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stamford Therapeutics Consortium</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Medical Associates</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Research, Inc.</name>
      <address>
        <city>Endwell</city>
        <state>New York</state>
        <zip>13706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Clinical Research Inc.</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cevac Center for vaccinology</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berliner Centrum für Reise- und Tropenmedizin (BCRT)</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20359</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>May 5, 2021</results_first_submitted>
  <results_first_submitted_qc>June 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 30, 2021</results_first_posted>
  <last_update_submitted>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>VLA15, Lyme Borreliosis, Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Borrelia Infections</mesh_term>
    <mesh_term>Lyme Disease</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03769194/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03769194/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>VLA15 Low Dose</title>
          <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
        </group>
        <group group_id="P2">
          <title>VLA15 Medium Dose</title>
          <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
        </group>
        <group group_id="P3">
          <title>VLA15 High Dose</title>
          <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="214"/>
                <participants group_id="P3" count="205"/>
                <participants group_id="P4" count="124"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="196"/>
                <participants group_id="P3" count="197"/>
                <participants group_id="P4" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>moved from study area</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>VLA15 Low Dose</title>
          <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
        </group>
        <group group_id="B2">
          <title>VLA15 Medium Dose</title>
          <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
        </group>
        <group group_id="B3">
          <title>VLA15 High Dose</title>
          <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
        </group>
        <group group_id="B5">
          <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="29"/>
            <count group_id="B2" value="214"/>
            <count group_id="B3" value="205"/>
            <count group_id="B4" value="124"/>
            <count group_id="B5" value="572"/>
          </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="29.2" spread="6.13"/>
                    <measurement group_id="B2" value="41.7" spread="13.26"/>
                    <measurement group_id="B3" value="41.6" spread="12.56"/>
                    <measurement group_id="B4" value="40.7" spread="12.80"/>
                    <measurement group_id="B5" value="40.8" spread="12.90"/>
                  </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="16"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="108"/>
                    <measurement group_id="B4" value="71"/>
                    <measurement group_id="B5" value="312"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="97"/>
                    <measurement group_id="B4" value="53"/>
                    <measurement group_id="B5" value="260"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>number of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="208"/>
                    <measurement group_id="B3" value="196"/>
                    <measurement group_id="B4" value="120"/>
                    <measurement group_id="B5" value="549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6</title>
        <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
        <time_frame>at Day 85 / Month 3</time_frame>
        <population>Overall Number of Participants Analyzed Per Protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6</title>
          <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
          <population>Overall Number of Participants Analyzed Per Protocol population</population>
          <units>U/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="194"/>
                <count group_id="O4" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ST1 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.3" lower_limit="46.4" upper_limit="119.0"/>
                    <measurement group_id="O2" value="101.9" lower_limit="87.1" upper_limit="119.4"/>
                    <measurement group_id="O3" value="115.8" lower_limit="98.8" upper_limit="135.7"/>
                    <measurement group_id="O4" value="21.7" lower_limit="20.0" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180.9" lower_limit="124.8" upper_limit="262.3"/>
                    <measurement group_id="O2" value="279.3" lower_limit="247.1" upper_limit="315.8"/>
                    <measurement group_id="O3" value="303.7" lower_limit="266.5" upper_limit="346.1"/>
                    <measurement group_id="O4" value="21.1" lower_limit="20.0" upper_limit="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="267.4" lower_limit="194.8" upper_limit="367.1"/>
                    <measurement group_id="O2" value="283.2" lower_limit="248.2" upper_limit="323.1"/>
                    <measurement group_id="O3" value="308.6" lower_limit="266.8" upper_limit="356.8"/>
                    <measurement group_id="O4" value="20.8" lower_limit="19.8" upper_limit="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.0" lower_limit="76.6" upper_limit="178.7"/>
                    <measurement group_id="O2" value="170.9" lower_limit="150.5" upper_limit="194.2"/>
                    <measurement group_id="O3" value="190.7" lower_limit="165.9" upper_limit="219.2"/>
                    <measurement group_id="O4" value="21.8" lower_limit="20.4" upper_limit="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.3" lower_limit="78.3" upper_limit="178.9"/>
                    <measurement group_id="O2" value="176.0" lower_limit="154.2" upper_limit="201.0"/>
                    <measurement group_id="O3" value="199.6" lower_limit="172.5" upper_limit="230.9"/>
                    <measurement group_id="O4" value="21.4" lower_limit="20.2" upper_limit="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.6" lower_limit="76.5" upper_limit="174.7"/>
                    <measurement group_id="O2" value="183.6" lower_limit="161.7" upper_limit="208.4"/>
                    <measurement group_id="O3" value="208.7" lower_limit="181.8" upper_limit="239.6"/>
                    <measurement group_id="O4" value="21.8" lower_limit="20.3" upper_limit="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)</title>
        <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)</title>
          <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
          <units>U/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="194"/>
                <count group_id="O4" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ST1 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.8" lower_limit="19.2" upper_limit="22.5"/>
                    <measurement group_id="O2" value="20.5" lower_limit="19.8" upper_limit="21.3"/>
                    <measurement group_id="O3" value="20.2" lower_limit="19.8" upper_limit="20.6"/>
                    <measurement group_id="O4" value="21.6" lower_limit="19.9" upper_limit="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="18.9" upper_limit="23.5"/>
                    <measurement group_id="O2" value="21.8" lower_limit="20.0" upper_limit="23.8"/>
                    <measurement group_id="O3" value="21.2" lower_limit="20.1" upper_limit="22.4"/>
                    <measurement group_id="O4" value="21.7" lower_limit="20.0" upper_limit="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.7" lower_limit="25.1" upper_limit="42.6"/>
                    <measurement group_id="O2" value="37.5" lower_limit="32.4" upper_limit="43.3"/>
                    <measurement group_id="O3" value="41.2" lower_limit="35.7" upper_limit="47.5"/>
                    <measurement group_id="O4" value="21.9" lower_limit="20.1" upper_limit="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" lower_limit="19.9" upper_limit="34.5"/>
                    <measurement group_id="O2" value="32.8" lower_limit="28.8" upper_limit="37.3"/>
                    <measurement group_id="O3" value="33.9" lower_limit="30.0" upper_limit="38.3"/>
                    <measurement group_id="O4" value="21.0" lower_limit="19.8" upper_limit="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" lower_limit="18.8" upper_limit="26.1"/>
                    <measurement group_id="O2" value="25.7" lower_limit="22.8" upper_limit="28.8"/>
                    <measurement group_id="O3" value="26.2" lower_limit="23.1" upper_limit="29.7"/>
                    <measurement group_id="O4" value="21.5" lower_limit="19.6" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" lower_limit="19.1" upper_limit="22.9"/>
                    <measurement group_id="O2" value="23.4" lower_limit="21.4" upper_limit="25.6"/>
                    <measurement group_id="O3" value="23.0" lower_limit="21.3" upper_limit="24.9"/>
                    <measurement group_id="O4" value="21.4" lower_limit="19.9" upper_limit="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" lower_limit="18.7" upper_limit="24.2"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O3" value="20.1" lower_limit="19.9" upper_limit="20.2"/>
                    <measurement group_id="O4" value="20.7" lower_limit="19.7" upper_limit="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="18.9" upper_limit="23.7"/>
                    <measurement group_id="O2" value="21.1" lower_limit="20.0" upper_limit="22.2"/>
                    <measurement group_id="O3" value="21.4" lower_limit="20.5" upper_limit="22.4"/>
                    <measurement group_id="O4" value="21.0" lower_limit="19.9" upper_limit="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.0" lower_limit="47.7" upper_limit="99.8"/>
                    <measurement group_id="O2" value="89.2" lower_limit="75.9" upper_limit="104.9"/>
                    <measurement group_id="O3" value="107.8" lower_limit="92.7" upper_limit="125.2"/>
                    <measurement group_id="O4" value="21.3" lower_limit="20.0" upper_limit="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2" lower_limit="29.3" upper_limit="57.9"/>
                    <measurement group_id="O2" value="62.5" lower_limit="54.5" upper_limit="71.7"/>
                    <measurement group_id="O3" value="67.1" lower_limit="58.3" upper_limit="77.1"/>
                    <measurement group_id="O4" value="20.6" lower_limit="19.7" upper_limit="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" lower_limit="21.2" upper_limit="33.4"/>
                    <measurement group_id="O2" value="36.8" lower_limit="32.1" upper_limit="42.2"/>
                    <measurement group_id="O3" value="35.7" lower_limit="30.9" upper_limit="41.2"/>
                    <measurement group_id="O4" value="20.5" lower_limit="19.5" upper_limit="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" lower_limit="19.2" upper_limit="24.7"/>
                    <measurement group_id="O2" value="24.6" lower_limit="22.8" upper_limit="26.6"/>
                    <measurement group_id="O3" value="24.8" lower_limit="23.1" upper_limit="26.6"/>
                    <measurement group_id="O4" value="20.6" lower_limit="19.7" upper_limit="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9" lower_limit="19.1" upper_limit="25.1"/>
                    <measurement group_id="O2" value="20.4" lower_limit="20.0" upper_limit="20.8"/>
                    <measurement group_id="O3" value="20.1" lower_limit="19.9" upper_limit="20.4"/>
                    <measurement group_id="O4" value="20.4" lower_limit="19.6" upper_limit="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" lower_limit="20.0" upper_limit="28.0"/>
                    <measurement group_id="O2" value="21.7" lower_limit="20.2" upper_limit="23.2"/>
                    <measurement group_id="O3" value="21.2" lower_limit="20.3" upper_limit="22.1"/>
                    <measurement group_id="O4" value="20.8" lower_limit="19.8" upper_limit="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.2" lower_limit="71.1" upper_limit="171.0"/>
                    <measurement group_id="O2" value="123.8" lower_limit="104.4" upper_limit="146.9"/>
                    <measurement group_id="O3" value="145.8" lower_limit="122.8" upper_limit="173.0"/>
                    <measurement group_id="O4" value="21.2" lower_limit="20.0" upper_limit="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1" lower_limit="35.6" upper_limit="79.1"/>
                    <measurement group_id="O2" value="63.1" lower_limit="55.2" upper_limit="72.2"/>
                    <measurement group_id="O3" value="68.7" lower_limit="59.5" upper_limit="79.2"/>
                    <measurement group_id="O4" value="20.5" lower_limit="19.8" upper_limit="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3" lower_limit="25.7" upper_limit="48.6"/>
                    <measurement group_id="O2" value="35.8" lower_limit="31.2" upper_limit="41.1"/>
                    <measurement group_id="O3" value="39.0" lower_limit="33.3" upper_limit="45.8"/>
                    <measurement group_id="O4" value="20.6" lower_limit="19.7" upper_limit="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2" lower_limit="19.9" upper_limit="31.8"/>
                    <measurement group_id="O2" value="25.6" lower_limit="23.5" upper_limit="27.9"/>
                    <measurement group_id="O3" value="27.0" lower_limit="24.5" upper_limit="29.8"/>
                    <measurement group_id="O4" value="20.5" lower_limit="19.8" upper_limit="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" lower_limit="18.7" upper_limit="24.4"/>
                    <measurement group_id="O2" value="21.0" lower_limit="20.3" upper_limit="21.7"/>
                    <measurement group_id="O3" value="20.2" lower_limit="19.9" upper_limit="20.6"/>
                    <measurement group_id="O4" value="21.7" lower_limit="20.3" upper_limit="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1" lower_limit="19.1" upper_limit="25.6"/>
                    <measurement group_id="O2" value="21.9" lower_limit="20.4" upper_limit="23.6"/>
                    <measurement group_id="O3" value="21.4" lower_limit="20.4" upper_limit="22.4"/>
                    <measurement group_id="O4" value="22.0" lower_limit="20.4" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9" lower_limit="32.8" upper_limit="64.2"/>
                    <measurement group_id="O2" value="57.4" lower_limit="49.5" upper_limit="66.6"/>
                    <measurement group_id="O3" value="64.7" lower_limit="55.5" upper_limit="75.5"/>
                    <measurement group_id="O4" value="22.0" lower_limit="20.4" upper_limit="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" lower_limit="24.1" upper_limit="44.6"/>
                    <measurement group_id="O2" value="48.1" lower_limit="42.5" upper_limit="54.5"/>
                    <measurement group_id="O3" value="49.3" lower_limit="43.1" upper_limit="56.3"/>
                    <measurement group_id="O4" value="21.5" lower_limit="20.2" upper_limit="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" lower_limit="20.6" upper_limit="31.5"/>
                    <measurement group_id="O2" value="32.8" lower_limit="29.0" upper_limit="37.2"/>
                    <measurement group_id="O3" value="31.9" lower_limit="27.7" upper_limit="36.6"/>
                    <measurement group_id="O4" value="21.7" lower_limit="20.0" upper_limit="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" lower_limit="19.2" upper_limit="24.7"/>
                    <measurement group_id="O2" value="26.5" lower_limit="24.2" upper_limit="28.9"/>
                    <measurement group_id="O3" value="25.5" lower_limit="23.2" upper_limit="27.9"/>
                    <measurement group_id="O4" value="21.7" lower_limit="20.3" upper_limit="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" lower_limit="19.4" upper_limit="21.8"/>
                    <measurement group_id="O2" value="20.7" lower_limit="20.1" upper_limit="21.3"/>
                    <measurement group_id="O3" value="20.2" lower_limit="19.8" upper_limit="20.5"/>
                    <measurement group_id="O4" value="21.4" lower_limit="20.2" upper_limit="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" lower_limit="19.2" upper_limit="22.4"/>
                    <measurement group_id="O2" value="21.2" lower_limit="20.0" upper_limit="22.5"/>
                    <measurement group_id="O3" value="21.0" lower_limit="20.2" upper_limit="21.9"/>
                    <measurement group_id="O4" value="21.4" lower_limit="20.1" upper_limit="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" lower_limit="29.8" upper_limit="61.3"/>
                    <measurement group_id="O2" value="57.9" lower_limit="44.9" upper_limit="67.2"/>
                    <measurement group_id="O3" value="72.2" lower_limit="61.6" upper_limit="84.7"/>
                    <measurement group_id="O4" value="21.5" lower_limit="20.2" upper_limit="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7" lower_limit="20.7" upper_limit="34.3"/>
                    <measurement group_id="O2" value="44.0" lower_limit="38.8" upper_limit="49.8"/>
                    <measurement group_id="O3" value="50.0" lower_limit="43.5" upper_limit="57.4"/>
                    <measurement group_id="O4" value="21.1" lower_limit="20.0" upper_limit="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0" lower_limit="19.6" upper_limit="27.0"/>
                    <measurement group_id="O2" value="31.0" lower_limit="27.5" upper_limit="35.0"/>
                    <measurement group_id="O3" value="32.4" lower_limit="28.0" upper_limit="37.4"/>
                    <measurement group_id="O4" value="21.5" lower_limit="20.0" upper_limit="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" lower_limit="19.3" upper_limit="24.3"/>
                    <measurement group_id="O2" value="24.0" lower_limit="22.3" upper_limit="25.8"/>
                    <measurement group_id="O3" value="24.9" lower_limit="22.7" upper_limit="27.2"/>
                    <measurement group_id="O4" value="21.1" lower_limit="20.0" upper_limit="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="18.9" upper_limit="23.5"/>
                    <measurement group_id="O2" value="21.3" lower_limit="20.4" upper_limit="22.2"/>
                    <measurement group_id="O3" value="20.8" lower_limit="20.1" upper_limit="21.6"/>
                    <measurement group_id="O4" value="21.6" lower_limit="20.2" upper_limit="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="18.9" upper_limit="23.6"/>
                    <measurement group_id="O2" value="22.7" lower_limit="21.2" upper_limit="24.3"/>
                    <measurement group_id="O3" value="22.0" lower_limit="20.9" upper_limit="23.2"/>
                    <measurement group_id="O4" value="22.0" lower_limit="20.4" upper_limit="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.3" lower_limit="29.8" upper_limit="60.1"/>
                    <measurement group_id="O2" value="55.5" lower_limit="48.1" upper_limit="64.1"/>
                    <measurement group_id="O3" value="65.3" lower_limit="55.6" upper_limit="76.7"/>
                    <measurement group_id="O4" value="22.1" lower_limit="20.4" upper_limit="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1" lower_limit="22.6" upper_limit="40.2"/>
                    <measurement group_id="O2" value="48.4" lower_limit="42.8" upper_limit="54.8"/>
                    <measurement group_id="O3" value="51.4" lower_limit="44.7" upper_limit="59.0"/>
                    <measurement group_id="O4" value="21.4" lower_limit="20.1" upper_limit="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6" lower_limit="20.7" upper_limit="31.8"/>
                    <measurement group_id="O2" value="33.4" lower_limit="29.5" upper_limit="37.8"/>
                    <measurement group_id="O3" value="33.2" lower_limit="28.6" upper_limit="38.6"/>
                    <measurement group_id="O4" value="22.1" lower_limit="20.2" upper_limit="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1" lower_limit="19.2" upper_limit="25.5"/>
                    <measurement group_id="O2" value="25.7" lower_limit="23.8" upper_limit="27.9"/>
                    <measurement group_id="O3" value="26.0" lower_limit="23.6" upper_limit="28.7"/>
                    <measurement group_id="O4" value="21.8" lower_limit="20.3" upper_limit="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),</title>
        <description>Seroconversion for ELISA is defined as:&#xD;
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a certain time point.&#xD;
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.&#xD;
Percentages are based on the number of subjects with non-missing observations.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),</title>
          <description>Seroconversion for ELISA is defined as:&#xD;
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a certain time point.&#xD;
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.&#xD;
Percentages are based on the number of subjects with non-missing observations.</description>
          <units>percentage of subjects</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="29"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="194"/>
                <count group_id="O4" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ST1 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="3.7" lower_limit="1.8" upper_limit="7.4"/>
                    <measurement group_id="O3" value="3.1" lower_limit="1.4" upper_limit="6.6"/>
                    <measurement group_id="O4" value="0.8" lower_limit="0.1" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3" lower_limit="23.6" upper_limit="57.6"/>
                    <measurement group_id="O2" value="37.2" lower_limit="30.6" upper_limit="44.2"/>
                    <measurement group_id="O3" value="40.7" lower_limit="34.1" upper_limit="47.8"/>
                    <measurement group_id="O4" value="1.7" lower_limit="0.5" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" lower_limit="4.0" upper_limit="29.0"/>
                    <measurement group_id="O2" value="32.8" lower_limit="26.4" upper_limit="39.9"/>
                    <measurement group_id="O3" value="35.4" lower_limit="29.0" upper_limit="42.5"/>
                    <measurement group_id="O4" value="0.9" lower_limit="0.2" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="2.1" upper_limit="24.1"/>
                    <measurement group_id="O2" value="17.2" lower_limit="11.5" upper_limit="24.9"/>
                    <measurement group_id="O3" value="18.5" lower_limit="12.5" upper_limit="26.4"/>
                    <measurement group_id="O4" value="2.6" lower_limit="0.7" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="0.7" upper_limit="19.5"/>
                    <measurement group_id="O2" value="10.9" lower_limit="7.2" upper_limit="16.3"/>
                    <measurement group_id="O3" value="8.9" lower_limit="5.6" upper_limit="13.8"/>
                    <measurement group_id="O4" value="1.8" lower_limit="0.5" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="2.6" lower_limit="1.1" upper_limit="6.0"/>
                    <measurement group_id="O3" value="5.7" lower_limit="3.2" upper_limit="9.9"/>
                    <measurement group_id="O4" value="0.8" lower_limit="0.1" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.9" lower_limit="49.3" upper_limit="82.1"/>
                    <measurement group_id="O2" value="72.3" lower_limit="65.5" upper_limit="78.1"/>
                    <measurement group_id="O3" value="79.9" lower_limit="73.7" upper_limit="84.9"/>
                    <measurement group_id="O4" value="1.7" lower_limit="0.5" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.3" lower_limit="25.5" upper_limit="61.1"/>
                    <measurement group_id="O2" value="66.1" lower_limit="59.0" upper_limit="72.6"/>
                    <measurement group_id="O3" value="66.7" lower_limit="59.7" upper_limit="73.0"/>
                    <measurement group_id="O4" value="0.9" lower_limit="0.2" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="8.5" upper_limit="37.9"/>
                    <measurement group_id="O2" value="42.6" lower_limit="34.2" upper_limit="51.5"/>
                    <measurement group_id="O3" value="38.7" lower_limit="30.4" upper_limit="47.6"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="2.2" upper_limit="25.0"/>
                    <measurement group_id="O2" value="15.3" lower_limit="10.8" upper_limit="21.2"/>
                    <measurement group_id="O3" value="17.8" lower_limit="13.0" upper_limit="23.8"/>
                    <measurement group_id="O4" value="0.9" lower_limit="0.2" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="1.9" upper_limit="22.0"/>
                    <measurement group_id="O2" value="4.2" lower_limit="2.1" upper_limit="8.0"/>
                    <measurement group_id="O3" value="3.6" lower_limit="1.8" upper_limit="7.3"/>
                    <measurement group_id="O4" value="1.7" lower_limit="0.5" upper_limit="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="56.6" upper_limit="87.3"/>
                    <measurement group_id="O2" value="80.1" lower_limit="73.9" upper_limit="85.1"/>
                    <measurement group_id="O3" value="84.0" lower_limit="78.2" upper_limit="88.5"/>
                    <measurement group_id="O4" value="2.5" lower_limit="0.8" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="32.1" upper_limit="67.9"/>
                    <measurement group_id="O2" value="68.9" lower_limit="61.8" upper_limit="75.1"/>
                    <measurement group_id="O3" value="69.3" lower_limit="62.4" upper_limit="75.4"/>
                    <measurement group_id="O4" value="1.8" lower_limit="0.5" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6" lower_limit="19.4" upper_limit="53.8"/>
                    <measurement group_id="O2" value="39.3" lower_limit="31.1" upper_limit="48.2"/>
                    <measurement group_id="O3" value="42.0" lower_limit="33.5" upper_limit="51.0"/>
                    <measurement group_id="O4" value="2.6" lower_limit="0.7" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="4.2" upper_limit="30.0"/>
                    <measurement group_id="O2" value="17.5" lower_limit="12.7" upper_limit="23.6"/>
                    <measurement group_id="O3" value="19.9" lower_limit="14.9" upper_limit="26.1"/>
                    <measurement group_id="O4" value="1.8" lower_limit="0.5" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="0.6" upper_limit="17.2"/>
                    <measurement group_id="O2" value="2.6" lower_limit="1.1" upper_limit="6.0"/>
                    <measurement group_id="O3" value="3.6" lower_limit="1.8" upper_limit="7.3"/>
                    <measurement group_id="O4" value="0.8" lower_limit="0.1" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="32.6" upper_limit="67.4"/>
                    <measurement group_id="O2" value="58.6" lower_limit="51.6" upper_limit="65.4"/>
                    <measurement group_id="O3" value="67.0" lower_limit="60.1" upper_limit="73.2"/>
                    <measurement group_id="O4" value="0.8" lower_limit="0.1" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8" lower_limit="16.5" upper_limit="50.0"/>
                    <measurement group_id="O2" value="57.4" lower_limit="50.1" upper_limit="64.3"/>
                    <measurement group_id="O3" value="58.2" lower_limit="51.1" upper_limit="65.0"/>
                    <measurement group_id="O4" value="0.9" lower_limit="0.2" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="6.2" upper_limit="33.5"/>
                    <measurement group_id="O2" value="36.1" lower_limit="28.1" upper_limit="44.9"/>
                    <measurement group_id="O3" value="31.9" lower_limit="24.2" upper_limit="40.8"/>
                    <measurement group_id="O4" value="1.3" lower_limit="0.2" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="2.2" upper_limit="25.0"/>
                    <measurement group_id="O2" value="19.7" lower_limit="14.6" upper_limit="26.0"/>
                    <measurement group_id="O3" value="16.8" lower_limit="12.1" upper_limit="22.7"/>
                    <measurement group_id="O4" value="2.7" lower_limit="0.9" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="1.6" lower_limit="0.5" upper_limit="4.5"/>
                    <measurement group_id="O3" value="2.6" lower_limit="1.1" upper_limit="5.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9" lower_limit="26.5" upper_limit="60.9"/>
                    <measurement group_id="O2" value="58.1" lower_limit="51.0" upper_limit="64.9"/>
                    <measurement group_id="O3" value="67.5" lower_limit="60.7" upper_limit="73.7"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="8.5" upper_limit="37.9"/>
                    <measurement group_id="O2" value="49.7" lower_limit="42.6" upper_limit="56.9"/>
                    <measurement group_id="O3" value="55.0" lower_limit="47.9" upper_limit="61.9"/>
                    <measurement group_id="O4" value="0.9" lower_limit="0.2" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" lower_limit="4.0" upper_limit="29.0"/>
                    <measurement group_id="O2" value="32.0" lower_limit="24.4" upper_limit="40.7"/>
                    <measurement group_id="O3" value="31.9" lower_limit="24.2" upper_limit="40.8"/>
                    <measurement group_id="O4" value="1.3" lower_limit="0.2" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="2.2" upper_limit="25.0"/>
                    <measurement group_id="O2" value="13.1" lower_limit="9.0" upper_limit="18.8"/>
                    <measurement group_id="O3" value="13.1" lower_limit="9.0" upper_limit="18.6"/>
                    <measurement group_id="O4" value="0.9" lower_limit="0.2" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="6.3" lower_limit="3.6" upper_limit="10.7"/>
                    <measurement group_id="O3" value="4.6" lower_limit="2.5" upper_limit="8.6"/>
                    <measurement group_id="O4" value="1.7" lower_limit="0.5" upper_limit="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9" lower_limit="26.5" upper_limit="60.9"/>
                    <measurement group_id="O2" value="54.5" lower_limit="47.4" upper_limit="61.4"/>
                    <measurement group_id="O3" value="60.3" lower_limit="53.3" upper_limit="66.9"/>
                    <measurement group_id="O4" value="1.7" lower_limit="0.5" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" lower_limit="11.0" upper_limit="42.1"/>
                    <measurement group_id="O2" value="54.1" lower_limit="46.9" upper_limit="61.2"/>
                    <measurement group_id="O3" value="53.4" lower_limit="46.3" upper_limit="60.4"/>
                    <measurement group_id="O4" value="2.6" lower_limit="0.9" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="6.2" upper_limit="33.5"/>
                    <measurement group_id="O2" value="35.2" lower_limit="27.3" upper_limit="44.1"/>
                    <measurement group_id="O3" value="31.1" lower_limit="23.5" upper_limit="39.9"/>
                    <measurement group_id="O4" value="3.9" lower_limit="1.4" upper_limit="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="2.2" upper_limit="25.0"/>
                    <measurement group_id="O2" value="16.9" lower_limit="12.2" upper_limit="23.0"/>
                    <measurement group_id="O3" value="13.6" lower_limit="9.5" upper_limit="19.2"/>
                    <measurement group_id="O4" value="3.5" lower_limit="1.4" upper_limit="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)</title>
        <description>GMFR (Geometric Mean of the Fold Rise as compared to baseline) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA.&#xD;
Calculations are based on number of subjects with non-missing results.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)</title>
          <description>GMFR (Geometric Mean of the Fold Rise as compared to baseline) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA.&#xD;
Calculations are based on number of subjects with non-missing results.</description>
          <units>Geometric Mean of the Fold Rise</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="29"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="194"/>
                <count group_id="O4" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ST1 Day 29</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="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.2" upper_limit="2.1"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.6" upper_limit="2.1"/>
                    <measurement group_id="O3" value="2.0" lower_limit="1.8" upper_limit="2.4"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="1.0" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.4" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.7" lower_limit="1.5" upper_limit="1.9"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.9" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.3" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.2" upper_limit="1.5"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.9" upper_limit="1.1"/>
                    <measurement group_id="O2" value="1.1" lower_limit="1.1" upper_limit="1.2"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.1" upper_limit="1.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 29</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="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" lower_limit="2.2" upper_limit="4.7"/>
                    <measurement group_id="O2" value="4.5" lower_limit="3.8" upper_limit="5.2"/>
                    <measurement group_id="O3" value="5.4" lower_limit="4.6" upper_limit="6.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="1.4" upper_limit="2.7"/>
                    <measurement group_id="O2" value="3.1" lower_limit="2.7" upper_limit="3.6"/>
                    <measurement group_id="O3" value="3.3" lower_limit="2.9" upper_limit="3.8"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="1.0" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.6" upper_limit="2.1"/>
                    <measurement group_id="O3" value="1.8" lower_limit="1.5" upper_limit="2.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.1" upper_limit="1.3"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.1" upper_limit="1.3"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 29</title>
              <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="1.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="3.2" upper_limit="7.8"/>
                    <measurement group_id="O2" value="6.1" lower_limit="5.1" upper_limit="7.2"/>
                    <measurement group_id="O3" value="7.2" lower_limit="6.1" upper_limit="8.6"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" lower_limit="1.6" upper_limit="3.6"/>
                    <measurement group_id="O2" value="3.1" lower_limit="2.7" upper_limit="3.5"/>
                    <measurement group_id="O3" value="3.4" lower_limit="3.0" upper_limit="3.9"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.2" upper_limit="2.2"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.5" upper_limit="2.0"/>
                    <measurement group_id="O3" value="1.9" lower_limit="1.6" upper_limit="2.3"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="1.0" upper_limit="1.4"/>
                    <measurement group_id="O2" value="1.3" lower_limit="1.2" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.2" upper_limit="1.5"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="1.5" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.7" lower_limit="2.4" upper_limit="3.2"/>
                    <measurement group_id="O3" value="3.2" lower_limit="2.7" upper_limit="3.7"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.1" upper_limit="2.1"/>
                    <measurement group_id="O2" value="2.3" lower_limit="2.0" upper_limit="2.6"/>
                    <measurement group_id="O3" value="2.4" lower_limit="2.1" upper_limit="2.8"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.9" upper_limit="1.5"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.4" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.6" lower_limit="1.4" upper_limit="1.8"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 365</title>
              <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="1.3" lower_limit="1.2" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 29</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="1.1"/>
                    <measurement group_id="O3" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="1.5" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.8" lower_limit="2.4" upper_limit="3.2"/>
                    <measurement group_id="O3" value="3.6" lower_limit="3.1" upper_limit="4.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="1.0" upper_limit="1.7"/>
                    <measurement group_id="O2" value="2.1" lower_limit="1.9" upper_limit="2.4"/>
                    <measurement group_id="O3" value="2.5" lower_limit="2.2" upper_limit="2.8"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.9" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.4" upper_limit="1.7"/>
                    <measurement group_id="O3" value="1.6" lower_limit="1.4" upper_limit="1.8"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.1" upper_limit="1.2"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.1" upper_limit="1.3"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 29</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="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.4" upper_limit="2.8"/>
                    <measurement group_id="O2" value="2.6" lower_limit="2.3" upper_limit="3.0"/>
                    <measurement group_id="O3" value="3.1" lower_limit="2.7" upper_limit="3.7"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="1.1" upper_limit="1.9"/>
                    <measurement group_id="O2" value="2.3" lower_limit="2.0" upper_limit="2.6"/>
                    <measurement group_id="O3" value="2.5" lower_limit="2.1" upper_limit="2.8"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="1.0" upper_limit="1.5"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.4" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.6" lower_limit="1.4" upper_limit="1.9"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="1.0" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.1" upper_limit="1.3"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years</title>
        <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 18 - 49 years.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years</title>
          <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 18 - 49 years.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
          <units>U/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="133"/>
                <count group_id="O3" value="136"/>
                <count group_id="O4" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ST1 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.8" lower_limit="19.2" upper_limit="22.5"/>
                    <measurement group_id="O2" value="20.3" lower_limit="19.7" upper_limit="21.0"/>
                    <measurement group_id="O3" value="20.3" lower_limit="19.7" upper_limit="20.8"/>
                    <measurement group_id="O4" value="22.0" lower_limit="19.6" upper_limit="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="18.9" upper_limit="23.5"/>
                    <measurement group_id="O2" value="20.9" lower_limit="19.7" upper_limit="22.1"/>
                    <measurement group_id="O3" value="21.4" lower_limit="19.9" upper_limit="23.0"/>
                    <measurement group_id="O4" value="22.0" lower_limit="19.6" upper_limit="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.7" lower_limit="25.1" upper_limit="42.6"/>
                    <measurement group_id="O2" value="34.8" lower_limit="30.0" upper_limit="40.3"/>
                    <measurement group_id="O3" value="43.6" lower_limit="36.5" upper_limit="52.0"/>
                    <measurement group_id="O4" value="22.4" lower_limit="19.9" upper_limit="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.3" lower_limit="46.4" upper_limit="119.0"/>
                    <measurement group_id="O2" value="105.2" lower_limit="88.8" upper_limit="124.5"/>
                    <measurement group_id="O3" value="129.6" lower_limit="107.6" upper_limit="156.2"/>
                    <measurement group_id="O4" value="21.9" lower_limit="19.6" upper_limit="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" lower_limit="19.9" upper_limit="34.5"/>
                    <measurement group_id="O2" value="31.7" lower_limit="27.5" upper_limit="36.4"/>
                    <measurement group_id="O3" value="34.7" lower_limit="29.7" upper_limit="40.5"/>
                    <measurement group_id="O4" value="21.0" lower_limit="19.5" upper_limit="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" lower_limit="18.8" upper_limit="26.1"/>
                    <measurement group_id="O2" value="26.1" lower_limit="22.5" upper_limit="30.3"/>
                    <measurement group_id="O3" value="26.4" lower_limit="22.4" upper_limit="31.2"/>
                    <measurement group_id="O4" value="21.7" lower_limit="19.3" upper_limit="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" lower_limit="19.1" upper_limit="22.9"/>
                    <measurement group_id="O2" value="23.0" lower_limit="21.1" upper_limit="25.1"/>
                    <measurement group_id="O3" value="23.8" lower_limit="21.4" upper_limit="26.5"/>
                    <measurement group_id="O4" value="21.7" lower_limit="19.7" upper_limit="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" lower_limit="18.7" upper_limit="24.2"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O3" value="20.1" lower_limit="19.9" upper_limit="20.3"/>
                    <measurement group_id="O4" value="21.0" lower_limit="19.6" upper_limit="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="18.9" upper_limit="23.7"/>
                    <measurement group_id="O2" value="20.7" lower_limit="19.9" upper_limit="21.5"/>
                    <measurement group_id="O3" value="21.4" lower_limit="20.5" upper_limit="22.3"/>
                    <measurement group_id="O4" value="21.0" lower_limit="19.6" upper_limit="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.0" lower_limit="47.7" upper_limit="99.8"/>
                    <measurement group_id="O2" value="89.5" lower_limit="74.2" upper_limit="107.9"/>
                    <measurement group_id="O3" value="121.4" lower_limit="102.4" upper_limit="143.9"/>
                    <measurement group_id="O4" value="21.4" lower_limit="19.8" upper_limit="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180.9" lower_limit="124.8" upper_limit="262.3"/>
                    <measurement group_id="O2" value="296.5" lower_limit="258.6" upper_limit="339.9"/>
                    <measurement group_id="O3" value="322.1" lower_limit="277.1" upper_limit="374.4"/>
                    <measurement group_id="O4" value="21.2" lower_limit="19.8" upper_limit="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2" lower_limit="29.3" upper_limit="57.9"/>
                    <measurement group_id="O2" value="64.5" lower_limit="54.7" upper_limit="76.0"/>
                    <measurement group_id="O3" value="71.8" lower_limit="60.8" upper_limit="84.7"/>
                    <measurement group_id="O4" value="20.5" lower_limit="19.5" upper_limit="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" lower_limit="21.2" upper_limit="33.4"/>
                    <measurement group_id="O2" value="39.6" lower_limit="33.5" upper_limit="46.8"/>
                    <measurement group_id="O3" value="37.0" lower_limit="31.2" upper_limit="43.9"/>
                    <measurement group_id="O4" value="20.6" lower_limit="19.4" upper_limit="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" lower_limit="19.2" upper_limit="24.7"/>
                    <measurement group_id="O2" value="24.5" lower_limit="22.4" upper_limit="26.8"/>
                    <measurement group_id="O3" value="25.1" lower_limit="23.0" upper_limit="27.4"/>
                    <measurement group_id="O4" value="20.5" lower_limit="19.5" upper_limit="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9" lower_limit="19.1" upper_limit="25.1"/>
                    <measurement group_id="O2" value="20.3" lower_limit="19.9" upper_limit="20.7"/>
                    <measurement group_id="O3" value="20.2" lower_limit="19.8" upper_limit="20.5"/>
                    <measurement group_id="O4" value="20.6" lower_limit="19.5" upper_limit="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" lower_limit="20.0" upper_limit="28.0"/>
                    <measurement group_id="O2" value="21.0" lower_limit="20.1" upper_limit="21.9"/>
                    <measurement group_id="O3" value="21.7" lower_limit="20.5" upper_limit="23.0"/>
                    <measurement group_id="O4" value="20.7" lower_limit="19.6" upper_limit="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.2" lower_limit="71.1" upper_limit="171.0"/>
                    <measurement group_id="O2" value="122.6" lower_limit="101.3" upper_limit="148.3"/>
                    <measurement group_id="O3" value="159.4" lower_limit="130.1" upper_limit="195.2"/>
                    <measurement group_id="O4" value="21.3" lower_limit="19.7" upper_limit="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="267.4" lower_limit="194.8" upper_limit="367.1"/>
                    <measurement group_id="O2" value="295.1" lower_limit="255.6" upper_limit="340.8"/>
                    <measurement group_id="O3" value="334.2" lower_limit="282.1" upper_limit="395.9"/>
                    <measurement group_id="O4" value="20.7" lower_limit="19.6" upper_limit="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1" lower_limit="35.6" upper_limit="79.1"/>
                    <measurement group_id="O2" value="60.7" lower_limit="51.7" upper_limit="71.2"/>
                    <measurement group_id="O3" value="73.0" lower_limit="61.3" upper_limit="86.9"/>
                    <measurement group_id="O4" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3" lower_limit="25.7" upper_limit="48.6"/>
                    <measurement group_id="O2" value="35.8" lower_limit="30.4" upper_limit="42.2"/>
                    <measurement group_id="O3" value="39.9" lower_limit="33.0" upper_limit="48.3"/>
                    <measurement group_id="O4" value="20.2" lower_limit="19.8" upper_limit="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2" lower_limit="19.9" upper_limit="31.8"/>
                    <measurement group_id="O2" value="25.4" lower_limit="23.2" upper_limit="27.8"/>
                    <measurement group_id="O3" value="28.0" lower_limit="24.7" upper_limit="31.8"/>
                    <measurement group_id="O4" value="20.2" lower_limit="19.8" upper_limit="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" lower_limit="18.7" upper_limit="24.4"/>
                    <measurement group_id="O2" value="20.8" lower_limit="20.0" upper_limit="21.6"/>
                    <measurement group_id="O3" value="20.3" lower_limit="19.9" upper_limit="20.8"/>
                    <measurement group_id="O4" value="22.0" lower_limit="20.2" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1" lower_limit="19.1" upper_limit="25.6"/>
                    <measurement group_id="O2" value="21.5" lower_limit="20.4" upper_limit="22.8"/>
                    <measurement group_id="O3" value="21.5" lower_limit="20.3" upper_limit="22.8"/>
                    <measurement group_id="O4" value="22.3" lower_limit="20.4" upper_limit="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9" lower_limit="32.8" upper_limit="64.2"/>
                    <measurement group_id="O2" value="56.9" lower_limit="48.3" upper_limit="67.1"/>
                    <measurement group_id="O3" value="71.4" lower_limit="59.1" upper_limit="86.3"/>
                    <measurement group_id="O4" value="22.4" lower_limit="20.4" upper_limit="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.0" lower_limit="76.6" upper_limit="178.7"/>
                    <measurement group_id="O2" value="177.1" lower_limit="154.5" upper_limit="203.1"/>
                    <measurement group_id="O3" value="206.8" lower_limit="175.0" upper_limit="244.3"/>
                    <measurement group_id="O4" value="22.1" lower_limit="20.3" upper_limit="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" lower_limit="24.1" upper_limit="44.6"/>
                    <measurement group_id="O2" value="48.2" lower_limit="41.8" upper_limit="55.6"/>
                    <measurement group_id="O3" value="53.2" lower_limit="44.9" upper_limit="63.0"/>
                    <measurement group_id="O4" value="21.7" lower_limit="20.0" upper_limit="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" lower_limit="20.6" upper_limit="31.5"/>
                    <measurement group_id="O2" value="34.9" lower_limit="29.9" upper_limit="40.8"/>
                    <measurement group_id="O3" value="33.6" lower_limit="28.1" upper_limit="40.1"/>
                    <measurement group_id="O4" value="21.2" lower_limit="19.5" upper_limit="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" lower_limit="19.2" upper_limit="24.7"/>
                    <measurement group_id="O2" value="26.7" lower_limit="24.2" upper_limit="29.5"/>
                    <measurement group_id="O3" value="26.7" lower_limit="23.5" upper_limit="30.3"/>
                    <measurement group_id="O4" value="21.4" lower_limit="19.9" upper_limit="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" lower_limit="19.4" upper_limit="21.8"/>
                    <measurement group_id="O2" value="20.4" lower_limit="19.9" upper_limit="20.9"/>
                    <measurement group_id="O3" value="20.2" lower_limit="19.8" upper_limit="20.8"/>
                    <measurement group_id="O4" value="21.5" lower_limit="20.0" upper_limit="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" lower_limit="19.2" upper_limit="22.4"/>
                    <measurement group_id="O2" value="20.6" lower_limit="19.9" upper_limit="21.3"/>
                    <measurement group_id="O3" value="21.1" lower_limit="20.1" upper_limit="22.1"/>
                    <measurement group_id="O4" value="21.4" lower_limit="20.0" upper_limit="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" lower_limit="29.8" upper_limit="61.3"/>
                    <measurement group_id="O2" value="56.6" lower_limit="47.8" upper_limit="67.0"/>
                    <measurement group_id="O3" value="80.7" lower_limit="66.3" upper_limit="98.1"/>
                    <measurement group_id="O4" value="21.6" lower_limit="20.0" upper_limit="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.3" lower_limit="78.3" upper_limit="178.9"/>
                    <measurement group_id="O2" value="180.7" lower_limit="156.8" upper_limit="208.2"/>
                    <measurement group_id="O3" value="218.3" lower_limit="183.6" upper_limit="259.7"/>
                    <measurement group_id="O4" value="21.4" lower_limit="20.0" upper_limit="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7" lower_limit="20.7" upper_limit="34.3"/>
                    <measurement group_id="O2" value="42.5" lower_limit="36.7" upper_limit="49.1"/>
                    <measurement group_id="O3" value="54.6" lower_limit="45.9" upper_limit="64.8"/>
                    <measurement group_id="O4" value="20.8" lower_limit="19.7" upper_limit="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0" lower_limit="19.6" upper_limit="27.0"/>
                    <measurement group_id="O2" value="31.9" lower_limit="27.5" upper_limit="37.1"/>
                    <measurement group_id="O3" value="33.4" lower_limit="27.7" upper_limit="40.2"/>
                    <measurement group_id="O4" value="21.0" lower_limit="19.6" upper_limit="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" lower_limit="19.3" upper_limit="24.3"/>
                    <measurement group_id="O2" value="24.0" lower_limit="22.2" upper_limit="26.0"/>
                    <measurement group_id="O3" value="26.0" lower_limit="23.0" upper_limit="29.5"/>
                    <measurement group_id="O4" value="20.8" lower_limit="19.7" upper_limit="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="18.9" upper_limit="23.5"/>
                    <measurement group_id="O2" value="20.8" lower_limit="20.0" upper_limit="21.5"/>
                    <measurement group_id="O3" value="21.2" lower_limit="20.1" upper_limit="22.4"/>
                    <measurement group_id="O4" value="21.7" lower_limit="20.0" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="18.9" upper_limit="23.6"/>
                    <measurement group_id="O2" value="22.3" lower_limit="21.0" upper_limit="23.7"/>
                    <measurement group_id="O3" value="22.2" lower_limit="20.8" upper_limit="23.7"/>
                    <measurement group_id="O4" value="22.1" lower_limit="20.3" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.3" lower_limit="29.8" upper_limit="60.1"/>
                    <measurement group_id="O2" value="54.5" lower_limit="46.2" upper_limit="64.3"/>
                    <measurement group_id="O3" value="72.3" lower_limit="59.2" upper_limit="88.3"/>
                    <measurement group_id="O4" value="22.3" lower_limit="20.3" upper_limit="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.6" lower_limit="76.5" upper_limit="174.7"/>
                    <measurement group_id="O2" value="185.8" lower_limit="162.2" upper_limit="213.0"/>
                    <measurement group_id="O3" value="225.6" lower_limit="191.9" upper_limit="265.3"/>
                    <measurement group_id="O4" value="21.8" lower_limit="20.1" upper_limit="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1" lower_limit="22.6" upper_limit="40.2"/>
                    <measurement group_id="O2" value="46.7" lower_limit="40.4" upper_limit="53.9"/>
                    <measurement group_id="O3" value="54.2" lower_limit="45.5" upper_limit="64.4"/>
                    <measurement group_id="O4" value="20.6" lower_limit="19.7" upper_limit="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6" lower_limit="20.7" upper_limit="31.8"/>
                    <measurement group_id="O2" value="34.6" lower_limit="29.8" upper_limit="40.2"/>
                    <measurement group_id="O3" value="34.6" lower_limit="28.7" upper_limit="41.9"/>
                    <measurement group_id="O4" value="21.4" lower_limit="19.7" upper_limit="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1" lower_limit="19.2" upper_limit="25.5"/>
                    <measurement group_id="O2" value="25.5" lower_limit="23.3" upper_limit="27.9"/>
                    <measurement group_id="O3" value="27.7" lower_limit="24.3" upper_limit="31.6"/>
                    <measurement group_id="O4" value="21.4" lower_limit="20.1" upper_limit="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years</title>
        <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 50 - 65 years.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <population>In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.</population>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years</title>
          <description>GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 50 - 65 years.&#xD;
GMTs are calculated based on the number of subjects with non-missing results.</description>
          <population>In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.</population>
          <units>U/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ST1 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="21.0" lower_limit="19.0" upper_limit="23.3"/>
                    <measurement group_id="O3" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O4" value="20.6" lower_limit="19.4" upper_limit="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="24.2" lower_limit="18.7" upper_limit="31.4"/>
                    <measurement group_id="O3" value="20.9" lower_limit="19.5" upper_limit="22.5"/>
                    <measurement group_id="O4" value="21.0" lower_limit="19.6" upper_limit="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="44.5" lower_limit="31.7" upper_limit="62.3"/>
                    <measurement group_id="O3" value="36.2" lower_limit="28.6" upper_limit="45.8"/>
                    <measurement group_id="O4" value="20.5" lower_limit="19.5" upper_limit="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="95.3" lower_limit="67.2" upper_limit="135.1"/>
                    <measurement group_id="O3" value="89.2" lower_limit="66.0" upper_limit="120.4"/>
                    <measurement group_id="O4" value="21.2" lower_limit="19.5" upper_limit="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="35.4" lower_limit="26.8" upper_limit="46.9"/>
                    <measurement group_id="O3" value="32.1" lower_limit="26.4" upper_limit="39.0"/>
                    <measurement group_id="O4" value="21.0" lower_limit="19.6" upper_limit="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="24.5" lower_limit="20.4" upper_limit="29.4"/>
                    <measurement group_id="O3" value="25.6" lower_limit="21.4" upper_limit="30.5"/>
                    <measurement group_id="O4" value="20.9" lower_limit="19.1" upper_limit="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="24.3" lower_limit="19.6" upper_limit="30.1"/>
                    <measurement group_id="O3" value="21.4" lower_limit="19.6" upper_limit="23.2"/>
                    <measurement group_id="O4" value="20.5" lower_limit="19.4" upper_limit="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O3" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O4" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="22.0" lower_limit="18.9" upper_limit="25.7"/>
                    <measurement group_id="O3" value="21.6" lower_limit="19.4" upper_limit="24.0"/>
                    <measurement group_id="O4" value="20.9" lower_limit="19.1" upper_limit="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="88.7" lower_limit="64.1" upper_limit="122.5"/>
                    <measurement group_id="O3" value="81.5" lower_limit="60.4" upper_limit="110.2"/>
                    <measurement group_id="O4" value="20.9" lower_limit="19.1" upper_limit="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="245.5" lower_limit="190.3" upper_limit="316.6"/>
                    <measurement group_id="O3" value="265.0" lower_limit="204.2" upper_limit="344.0"/>
                    <measurement group_id="O4" value="20.8" lower_limit="19.2" upper_limit="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="58.5" lower_limit="45.4" upper_limit="75.3"/>
                    <measurement group_id="O3" value="57.4" lower_limit="44.1" upper_limit="74.5"/>
                    <measurement group_id="O4" value="20.8" lower_limit="19.2" upper_limit="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="30.5" lower_limit="24.1" upper_limit="38.7"/>
                    <measurement group_id="O3" value="32.7" lower_limit="24.8" upper_limit="43.1"/>
                    <measurement group_id="O4" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="24.9" lower_limit="21.3" upper_limit="29.2"/>
                    <measurement group_id="O3" value="24.1" lower_limit="21.3" upper_limit="27.3"/>
                    <measurement group_id="O4" value="20.9" lower_limit="19.1" upper_limit="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="20.7" lower_limit="19.7" upper_limit="21.7"/>
                    <measurement group_id="O3" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O4" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="23.3" lower_limit="18.9" upper_limit="28.7"/>
                    <measurement group_id="O3" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O4" value="21.2" lower_limit="18.8" upper_limit="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="126.7" lower_limit="88.0" upper_limit="182.4"/>
                    <measurement group_id="O3" value="118.3" lower_limit="85.7" upper_limit="163.1"/>
                    <measurement group_id="O4" value="21.1" lower_limit="18.9" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="258.9" lower_limit="194.9" upper_limit="343.8"/>
                    <measurement group_id="O3" value="256.5" lower_limit="193.5" upper_limit="340.0"/>
                    <measurement group_id="O4" value="21.1" lower_limit="19.0" upper_limit="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="68.8" lower_limit="53.5" upper_limit="88.4"/>
                    <measurement group_id="O3" value="59.7" lower_limit="46.4" upper_limit="76.7"/>
                    <measurement group_id="O4" value="21.9" lower_limit="19.1" upper_limit="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="35.7" lower_limit="27.3" upper_limit="46.8"/>
                    <measurement group_id="O3" value="36.9" lower_limit="27.2" upper_limit="50.1"/>
                    <measurement group_id="O4" value="22.0" lower_limit="18.0" upper_limit="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="26.0" lower_limit="21.5" upper_limit="31.5"/>
                    <measurement group_id="O3" value="24.8" lower_limit="21.6" upper_limit="28.4"/>
                    <measurement group_id="O4" value="21.3" lower_limit="18.7" upper_limit="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="21.3" lower_limit="19.8" upper_limit="23.0"/>
                    <measurement group_id="O3" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O4" value="20.9" lower_limit="19.1" upper_limit="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="22.9" lower_limit="18.7" upper_limit="28.0"/>
                    <measurement group_id="O3" value="21.0" lower_limit="19.4" upper_limit="22.8"/>
                    <measurement group_id="O4" value="21.2" lower_limit="18.8" upper_limit="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="58.6" lower_limit="42.6" upper_limit="80.6"/>
                    <measurement group_id="O3" value="51.4" lower_limit="39.8" upper_limit="66.4"/>
                    <measurement group_id="O4" value="21.2" lower_limit="18.8" upper_limit="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="158.2" lower_limit="119.5" upper_limit="209.4"/>
                    <measurement group_id="O3" value="158.1" lower_limit="122.5" upper_limit="203.9"/>
                    <measurement group_id="O4" value="21.1" lower_limit="18.9" upper_limit="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="48.0" lower_limit="37.5" upper_limit="61.5"/>
                    <measurement group_id="O3" value="41.3" lower_limit="33.6" upper_limit="50.9"/>
                    <measurement group_id="O4" value="21.1" lower_limit="18.9" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="28.0" lower_limit="23.1" upper_limit="33.8"/>
                    <measurement group_id="O3" value="28.0" lower_limit="22.7" upper_limit="34.7"/>
                    <measurement group_id="O4" value="23.1" lower_limit="18.7" upper_limit="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="26.0" lower_limit="21.7" upper_limit="31.1"/>
                    <measurement group_id="O3" value="22.9" lower_limit="20.9" upper_limit="25.1"/>
                    <measurement group_id="O4" value="22.5" lower_limit="19.4" upper_limit="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="21.4" lower_limit="19.8" upper_limit="23.0"/>
                    <measurement group_id="O3" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O4" value="21.0" lower_limit="19.0" upper_limit="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="22.7" lower_limit="19.0" upper_limit="27.1"/>
                    <measurement group_id="O3" value="20.8" lower_limit="19.2" upper_limit="22.6"/>
                    <measurement group_id="O4" value="21.3" lower_limit="18.7" upper_limit="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="61.0" lower_limit="44.9" upper_limit="82.9"/>
                    <measurement group_id="O3" value="55.7" lower_limit="42.5" upper_limit="72.8"/>
                    <measurement group_id="O4" value="21.3" lower_limit="18.7" upper_limit="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="166.4" lower_limit="124.1" upper_limit="223.0"/>
                    <measurement group_id="O3" value="162.1" lower_limit="124.0" upper_limit="211.9"/>
                    <measurement group_id="O4" value="21.2" lower_limit="18.8" upper_limit="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="47.4" lower_limit="37.2" upper_limit="60.5"/>
                    <measurement group_id="O3" value="40.8" lower_limit="32.6" upper_limit="51.1"/>
                    <measurement group_id="O4" value="21.9" lower_limit="19.1" upper_limit="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="28.8" lower_limit="23.4" upper_limit="35.6"/>
                    <measurement group_id="O3" value="30.2" lower_limit="24.1" upper_limit="37.7"/>
                    <measurement group_id="O4" value="23.1" lower_limit="18.6" upper_limit="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="23.9" lower_limit="20.5" upper_limit="27.8"/>
                    <measurement group_id="O3" value="22.4" lower_limit="20.2" upper_limit="24.7"/>
                    <measurement group_id="O4" value="21.9" lower_limit="19.1" upper_limit="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="22.6" lower_limit="20.3" upper_limit="25.1"/>
                    <measurement group_id="O3" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O4" value="21.4" lower_limit="18.7" upper_limit="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="23.6" lower_limit="19.9" upper_limit="28.1"/>
                    <measurement group_id="O3" value="21.6" lower_limit="19.6" upper_limit="23.9"/>
                    <measurement group_id="O4" value="21.7" lower_limit="18.3" upper_limit="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="58.0" lower_limit="43.2" upper_limit="77.7"/>
                    <measurement group_id="O3" value="51.4" lower_limit="39.3" upper_limit="67.1"/>
                    <measurement group_id="O4" value="21.7" lower_limit="18.4" upper_limit="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="178.7" lower_limit="136.2" upper_limit="236.3"/>
                    <measurement group_id="O3" value="174.3" lower_limit="133.9" upper_limit="226.9"/>
                    <measurement group_id="O4" value="21.6" lower_limit="18.5" upper_limit="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="52.3" lower_limit="41.1" upper_limit="66.5"/>
                    <measurement group_id="O3" value="45.5" lower_limit="36.1" upper_limit="57.3"/>
                    <measurement group_id="O4" value="23.6" lower_limit="19.2" upper_limit="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="30.3" lower_limit="24.1" upper_limit="38.1"/>
                    <measurement group_id="O3" value="30.1" lower_limit="23.6" upper_limit="38.3"/>
                    <measurement group_id="O4" value="24.6" lower_limit="18.0" upper_limit="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="26.2" lower_limit="22.2" upper_limit="30.9"/>
                    <measurement group_id="O3" value="22.5" lower_limit="20.2" upper_limit="25.0"/>
                    <measurement group_id="O4" value="22.8" lower_limit="18.7" upper_limit="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years</title>
        <description>SCRs (Seroconversion Rate) for Seroconversion for ELISA is defined as:&#xD;
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point.&#xD;
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.&#xD;
Percentages are based on the number of subjects with non-missing observations.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years</title>
          <description>SCRs (Seroconversion Rate) for Seroconversion for ELISA is defined as:&#xD;
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point.&#xD;
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.&#xD;
Percentages are based on the number of subjects with non-missing observations.</description>
          <units>percentage of subjects</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="29"/>
                <count group_id="O2" value="133"/>
                <count group_id="O3" value="136"/>
                <count group_id="O4" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ST1 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="2.3" lower_limit="0.8" upper_limit="6.4"/>
                    <measurement group_id="O3" value="2.9" lower_limit="1.1" upper_limit="7.3"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3" lower_limit="23.6" upper_limit="57.6"/>
                    <measurement group_id="O2" value="36.1" lower_limit="28.4" upper_limit="44.5"/>
                    <measurement group_id="O3" value="43.4" lower_limit="35.3" upper_limit="51.8"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.2" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4" lower_limit="46.2" upper_limit="80.6"/>
                    <measurement group_id="O2" value="85.9" lower_limit="78.9" upper_limit="90.9"/>
                    <measurement group_id="O3" value="85.6" lower_limit="78.6" upper_limit="90.6"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" lower_limit="4.0" upper_limit="29.0"/>
                    <measurement group_id="O2" value="31.2" lower_limit="23.7" upper_limit="39.8"/>
                    <measurement group_id="O3" value="36.4" lower_limit="28.7" upper_limit="44.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="2.1" upper_limit="24.1"/>
                    <measurement group_id="O2" value="18.2" lower_limit="11.5" upper_limit="27.5"/>
                    <measurement group_id="O3" value="17.9" lower_limit="11.1" upper_limit="27.4"/>
                    <measurement group_id="O4" value="1.7" lower_limit="0.3" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="0.7" upper_limit="19.5"/>
                    <measurement group_id="O2" value="11.3" lower_limit="6.8" upper_limit="18.1"/>
                    <measurement group_id="O3" value="10.5" lower_limit="6.4" upper_limit="16.9"/>
                    <measurement group_id="O4" value="1.2" lower_limit="0.2" upper_limit="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="2.3" lower_limit="0.8" upper_limit="6.4"/>
                    <measurement group_id="O3" value="6.6" lower_limit="3.5" upper_limit="12.1"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.9" lower_limit="49.3" upper_limit="82.1"/>
                    <measurement group_id="O2" value="72.9" lower_limit="64.8" upper_limit="79.8"/>
                    <measurement group_id="O3" value="85.3" lower_limit="78.4" upper_limit="90.3"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.2" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.5" lower_limit="71.0" upper_limit="96.0"/>
                    <measurement group_id="O2" value="100" lower_limit="97.1" upper_limit="100"/>
                    <measurement group_id="O3" value="96.2" lower_limit="91.4" upper_limit="98.4"/>
                    <measurement group_id="O4" value="1.2" lower_limit="0.2" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.3" lower_limit="25.5" upper_limit="61.1"/>
                    <measurement group_id="O2" value="68.0" lower_limit="59.4" upper_limit="75.5"/>
                    <measurement group_id="O3" value="69.7" lower_limit="61.4" upper_limit="76.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="8.5" upper_limit="37.9"/>
                    <measurement group_id="O2" value="47.7" lower_limit="37.6" upper_limit="58.0"/>
                    <measurement group_id="O3" value="41.7" lower_limit="31.7" upper_limit="52.3"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="2.2" upper_limit="25.0"/>
                    <measurement group_id="O2" value="15.3" lower_limit="10.0" upper_limit="22.7"/>
                    <measurement group_id="O3" value="18.8" lower_limit="13.1" upper_limit="26.3"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="1.9" upper_limit="22.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="1.2" upper_limit="7.5"/>
                    <measurement group_id="O3" value="5.1" lower_limit="2.5" upper_limit="10.2"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.2" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="56.6" upper_limit="87.3"/>
                    <measurement group_id="O2" value="81.2" lower_limit="73.7" upper_limit="86.9"/>
                    <measurement group_id="O3" value="85.3" lower_limit="78.4" upper_limit="90.3"/>
                    <measurement group_id="O4" value="2.3" lower_limit="0.6" upper_limit="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.2" lower_limit="81.1" upper_limit="99.3"/>
                    <measurement group_id="O2" value="98.4" lower_limit="94.5" upper_limit="99.6"/>
                    <measurement group_id="O3" value="97.0" lower_limit="92.5" upper_limit="98.8"/>
                    <measurement group_id="O4" value="1.2" lower_limit="0.2" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="32.1" upper_limit="67.9"/>
                    <measurement group_id="O2" value="66.4" lower_limit="57.7" upper_limit="74.1"/>
                    <measurement group_id="O3" value="70.5" lower_limit="62.2" upper_limit="77.6"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6" lower_limit="19.4" upper_limit="53.8"/>
                    <measurement group_id="O2" value="39.8" lower_limit="30.2" upper_limit="50.2"/>
                    <measurement group_id="O3" value="44.0" lower_limit="33.9" upper_limit="54.7"/>
                    <measurement group_id="O4" value="1.7" lower_limit="0.3" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="4.2" upper_limit="30.0"/>
                    <measurement group_id="O2" value="19.4" lower_limit="13.4" upper_limit="27.2"/>
                    <measurement group_id="O3" value="21.8" lower_limit="15.6" upper_limit="29.6"/>
                    <measurement group_id="O4" value="1.2" lower_limit="0.2" upper_limit="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="0.6" upper_limit="17.2"/>
                    <measurement group_id="O2" value="2.3" lower_limit="0.8" upper_limit="6.5"/>
                    <measurement group_id="O3" value="3.7" lower_limit="1.6" upper_limit="8.3"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.2" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="32.6" upper_limit="67.4"/>
                    <measurement group_id="O2" value="60.2" lower_limit="51.7" upper_limit="68.1"/>
                    <measurement group_id="O3" value="71.3" lower_limit="63.2" upper_limit="78.3"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.2" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.8" lower_limit="62.1" upper_limit="91.5"/>
                    <measurement group_id="O2" value="96.1" lower_limit="91.2" upper_limit="98.3"/>
                    <measurement group_id="O3" value="94.7" lower_limit="89.5" upper_limit="97.4"/>
                    <measurement group_id="O4" value="1.2" lower_limit="0.2" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8" lower_limit="16.5" upper_limit="50.0"/>
                    <measurement group_id="O2" value="58.4" lower_limit="49.6" upper_limit="66.7"/>
                    <measurement group_id="O3" value="60.6" lower_limit="52.1" upper_limit="68.5"/>
                    <measurement group_id="O4" value="1.2" lower_limit="0.2" upper_limit="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="6.2" upper_limit="33.5"/>
                    <measurement group_id="O2" value="38.6" lower_limit="29.1" upper_limit="49.1"/>
                    <measurement group_id="O3" value="34.5" lower_limit="25.2" upper_limit="45.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="2.2" upper_limit="25.0"/>
                    <measurement group_id="O2" value="21.0" lower_limit="14.7" upper_limit="29.0"/>
                    <measurement group_id="O3" value="18.0" lower_limit="12.4" upper_limit="25.4"/>
                    <measurement group_id="O4" value="1.2" lower_limit="0.2" upper_limit="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.1" upper_limit="4.1"/>
                    <measurement group_id="O3" value="2.9" lower_limit="1.1" upper_limit="7.3"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9" lower_limit="26.5" upper_limit="60.9"/>
                    <measurement group_id="O2" value="59.4" lower_limit="50.9" upper_limit="67.4"/>
                    <measurement group_id="O3" value="72.8" lower_limit="64.8" upper_limit="79.6"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.8" lower_limit="62.1" upper_limit="91.5"/>
                    <measurement group_id="O2" value="94.5" lower_limit="89.1" upper_limit="97.3"/>
                    <measurement group_id="O3" value="91.7" lower_limit="85.7" upper_limit="95.3"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="8.5" upper_limit="37.9"/>
                    <measurement group_id="O2" value="48.8" lower_limit="40.2" upper_limit="57.5"/>
                    <measurement group_id="O3" value="59.1" lower_limit="50.6" upper_limit="67.1"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" lower_limit="4.0" upper_limit="29.0"/>
                    <measurement group_id="O2" value="33.0" lower_limit="24.0" upper_limit="43.3"/>
                    <measurement group_id="O3" value="32.1" lower_limit="23.1" upper_limit="42.7"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="2.2" upper_limit="25.0"/>
                    <measurement group_id="O2" value="15.3" lower_limit="10.0" upper_limit="22.7"/>
                    <measurement group_id="O3" value="15.0" lower_limit="10.0" upper_limit="22.1"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="6.8" lower_limit="3.6" upper_limit="12.4"/>
                    <measurement group_id="O3" value="4.4" lower_limit="2.0" upper_limit="9.3"/>
                    <measurement group_id="O4" value="2.3" lower_limit="0.6" upper_limit="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9" lower_limit="26.5" upper_limit="60.9"/>
                    <measurement group_id="O2" value="55.6" lower_limit="47.2" upper_limit="63.8"/>
                    <measurement group_id="O3" value="64.0" lower_limit="55.6" upper_limit="71.6"/>
                    <measurement group_id="O4" value="2.3" lower_limit="0.6" upper_limit="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.8" lower_limit="62.1" upper_limit="91.5"/>
                    <measurement group_id="O2" value="95.3" lower_limit="90.2" upper_limit="97.8"/>
                    <measurement group_id="O3" value="92.4" lower_limit="86.6" upper_limit="95.8"/>
                    <measurement group_id="O4" value="1.2" lower_limit="0.2" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" lower_limit="11.0" upper_limit="42.1"/>
                    <measurement group_id="O2" value="54.4" lower_limit="45.7" upper_limit="62.9"/>
                    <measurement group_id="O3" value="53.8" lower_limit="45.3" upper_limit="62.1"/>
                    <measurement group_id="O4" value="1.2" lower_limit="0.2" upper_limit="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="6.2" upper_limit="33.5"/>
                    <measurement group_id="O2" value="38.6" lower_limit="29.1" upper_limit="49.1"/>
                    <measurement group_id="O3" value="32.1" lower_limit="23.1" upper_limit="42.7"/>
                    <measurement group_id="O4" value="3.4" lower_limit="1.0" upper_limit="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="2.2" upper_limit="25.0"/>
                    <measurement group_id="O2" value="17.7" lower_limit="12.0" upper_limit="25.4"/>
                    <measurement group_id="O3" value="15.8" lower_limit="10.6" upper_limit="22.9"/>
                    <measurement group_id="O4" value="3.7" lower_limit="1.3" upper_limit="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years</title>
        <description>Seroconversion for ELISA is defined as:&#xD;
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point.&#xD;
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.&#xD;
Percentages are based on the number of subjects with non-missing observations.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <population>In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.</population>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years</title>
          <description>Seroconversion for ELISA is defined as:&#xD;
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point.&#xD;
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.&#xD;
Percentages are based on the number of subjects with non-missing observations.</description>
          <population>In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.</population>
          <units>percentage of subjects</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="0"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ST1 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6.9" lower_limit="2.7" upper_limit="16.4"/>
                    <measurement group_id="O3" value="3.4" lower_limit="1.0" upper_limit="11.7"/>
                    <measurement group_id="O4" value="3.1" lower_limit="0.6" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="39.7" lower_limit="28.1" upper_limit="52.5"/>
                    <measurement group_id="O3" value="34.5" lower_limit="23.6" upper_limit="47.3"/>
                    <measurement group_id="O4" value="3.0" lower_limit="0.5" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="71.2" lower_limit="58.6" upper_limit="81.2"/>
                    <measurement group_id="O3" value="71.9" lower_limit="59.2" upper_limit="81.9"/>
                    <measurement group_id="O4" value="3.0" lower_limit="0.5" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="36.2" lower_limit="25.1" upper_limit="49.1"/>
                    <measurement group_id="O3" value="33.3" lower_limit="22.5" upper_limit="46.3"/>
                    <measurement group_id="O4" value="3.1" lower_limit="0.6" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="14.7" lower_limit="6.4" upper_limit="30.1"/>
                    <measurement group_id="O3" value="20.0" lower_limit="10.0" upper_limit="35.9"/>
                    <measurement group_id="O4" value="5.6" lower_limit="1.0" upper_limit="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="10.2" lower_limit="4.7" upper_limit="20.5"/>
                    <measurement group_id="O3" value="5.2" lower_limit="1.8" upper_limit="14.1"/>
                    <measurement group_id="O4" value="3.2" lower_limit="0.6" upper_limit="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.4" lower_limit="1.0" upper_limit="11.7"/>
                    <measurement group_id="O3" value="3.4" lower_limit="1.0" upper_limit="11.7"/>
                    <measurement group_id="O4" value="3.1" lower_limit="0.6" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="70.7" lower_limit="58.0" upper_limit="80.8"/>
                    <measurement group_id="O3" value="67.2" lower_limit="54.4" upper_limit="77.9"/>
                    <measurement group_id="O4" value="3.0" lower_limit="0.5" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="94.9" lower_limit="86.1" upper_limit="98.3"/>
                    <measurement group_id="O3" value="93.0" lower_limit="83.3" upper_limit="97.2"/>
                    <measurement group_id="O4" value="3.0" lower_limit="0.5" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="62.1" lower_limit="49.2" upper_limit="73.4"/>
                    <measurement group_id="O3" value="59.6" lower_limit="46.7" upper_limit="71.4"/>
                    <measurement group_id="O4" value="3.1" lower_limit="0.6" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="29.4" lower_limit="16.8" upper_limit="46.2"/>
                    <measurement group_id="O3" value="31.4" lower_limit="18.6" upper_limit="48.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="15.3" lower_limit="8.2" upper_limit="26.5"/>
                    <measurement group_id="O3" value="15.5" lower_limit="8.4" upper_limit="26.9"/>
                    <measurement group_id="O4" value="3.2" lower_limit="0.6" upper_limit="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6.9" lower_limit="2.7" upper_limit="16.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="6.2"/>
                    <measurement group_id="O4" value="3.1" lower_limit="0.6" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="77.6" lower_limit="65.3" upper_limit="86.4"/>
                    <measurement group_id="O3" value="81.0" lower_limit="69.1" upper_limit="89.1"/>
                    <measurement group_id="O4" value="3.0" lower_limit="0.5" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="94.9" lower_limit="86.1" upper_limit="98.3"/>
                    <measurement group_id="O3" value="93.0" lower_limit="83.3" upper_limit="97.2"/>
                    <measurement group_id="O4" value="3.0" lower_limit="0.5" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="74.1" lower_limit="61.6" upper_limit="83.7"/>
                    <measurement group_id="O3" value="66.7" lower_limit="53.7" upper_limit="77.5"/>
                    <measurement group_id="O4" value="6.3" lower_limit="1.7" upper_limit="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="38.2" lower_limit="23.9" upper_limit="55.0"/>
                    <measurement group_id="O3" value="37.1" lower_limit="23.2" upper_limit="53.7"/>
                    <measurement group_id="O4" value="5.6" lower_limit="1.0" upper_limit="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="13.6" lower_limit="7.0" upper_limit="24.5"/>
                    <measurement group_id="O3" value="15.5" lower_limit="8.4" upper_limit="26.9"/>
                    <measurement group_id="O4" value="3.2" lower_limit="0.6" upper_limit="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.4" lower_limit="1.0" upper_limit="11.7"/>
                    <measurement group_id="O3" value="3.4" lower_limit="1.0" upper_limit="11.7"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="55.2" lower_limit="42.5" upper_limit="67.3"/>
                    <measurement group_id="O3" value="56.9" lower_limit="44.1" upper_limit="68.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="89.8" lower_limit="79.5" upper_limit="95.3"/>
                    <measurement group_id="O3" value="91.2" lower_limit="81.1" upper_limit="96.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="55.2" lower_limit="42.5" upper_limit="67.3"/>
                    <measurement group_id="O3" value="52.6" lower_limit="39.9" upper_limit="65.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="29.4" lower_limit="16.8" upper_limit="46.2"/>
                    <measurement group_id="O3" value="25.7" lower_limit="14.2" upper_limit="42.1"/>
                    <measurement group_id="O4" value="5.6" lower_limit="1.0" upper_limit="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="16.9" lower_limit="9.5" upper_limit="28.5"/>
                    <measurement group_id="O3" value="13.8" lower_limit="7.2" upper_limit="24.9"/>
                    <measurement group_id="O4" value="6.5" lower_limit="1.8" upper_limit="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.4" lower_limit="1.0" upper_limit="11.7"/>
                    <measurement group_id="O3" value="1.7" lower_limit="0.3" upper_limit="9.1"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="55.2" lower_limit="42.5" upper_limit="67.3"/>
                    <measurement group_id="O3" value="55.2" lower_limit="42.5" upper_limit="67.3"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="84.7" lower_limit="73.5" upper_limit="91.8"/>
                    <measurement group_id="O3" value="87.7" lower_limit="76.8" upper_limit="93.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="51.7" lower_limit="39.2" upper_limit="64.1"/>
                    <measurement group_id="O3" value="45.6" lower_limit="33.4" upper_limit="58.4"/>
                    <measurement group_id="O4" value="3.1" lower_limit="0.6" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="29.4" lower_limit="16.8" upper_limit="46.2"/>
                    <measurement group_id="O3" value="31.4" lower_limit="18.6" upper_limit="48.0"/>
                    <measurement group_id="O4" value="5.6" lower_limit="1.0" upper_limit="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="8.5" lower_limit="3.7" upper_limit="18.4"/>
                    <measurement group_id="O3" value="8.6" lower_limit="3.7" upper_limit="18.6"/>
                    <measurement group_id="O4" value="3.2" lower_limit="0.6" upper_limit="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5.2" lower_limit="1.8" upper_limit="14.1"/>
                    <measurement group_id="O3" value="5.2" lower_limit="1.8" upper_limit="14.1"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="51.7" lower_limit="39.2" upper_limit="64.1"/>
                    <measurement group_id="O3" value="51.7" lower_limit="39.2" upper_limit="64.1"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="88.1" lower_limit="77.5" upper_limit="94.1"/>
                    <measurement group_id="O3" value="89.5" lower_limit="78.9" upper_limit="95.1"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="53.4" lower_limit="40.8" upper_limit="65.7"/>
                    <measurement group_id="O3" value="52.6" lower_limit="39.9" upper_limit="65.0"/>
                    <measurement group_id="O4" value="6.3" lower_limit="1.7" upper_limit="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="26.5" lower_limit="14.6" upper_limit="43.1"/>
                    <measurement group_id="O3" value="28.6" lower_limit="16.3" upper_limit="45.1"/>
                    <measurement group_id="O4" value="5.6" lower_limit="1.0" upper_limit="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="15.3" lower_limit="8.2" upper_limit="26.5"/>
                    <measurement group_id="O3" value="8.6" lower_limit="3.7" upper_limit="18.6"/>
                    <measurement group_id="O4" value="3.2" lower_limit="0.6" upper_limit="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years</title>
        <description>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 18 - 49 years.&#xD;
Calculations are based on number of subjects with non-missing results.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years</title>
          <description>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 18 - 49 years.&#xD;
Calculations are based on number of subjects with non-missing results.</description>
          <units>Geometric Mean of the Fold Rise</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="29"/>
                <count group_id="O2" value="133"/>
                <count group_id="O3" value="136"/>
                <count group_id="O4" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ST1 Day 29</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="1.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.2" upper_limit="2.1"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.5" upper_limit="2.0"/>
                    <measurement group_id="O3" value="2.2" lower_limit="1.8" upper_limit="2.6"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.2" upper_limit="5.6"/>
                    <measurement group_id="O2" value="5.3" lower_limit="4.4" upper_limit="6.2"/>
                    <measurement group_id="O3" value="6.4" lower_limit="5.3" upper_limit="7.7"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="1.0" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.4" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.7" lower_limit="1.5" upper_limit="2.0"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.9" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.3" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.1" upper_limit="1.6"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.9" upper_limit="1.1"/>
                    <measurement group_id="O2" value="1.1" lower_limit="1.1" upper_limit="1.2"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.1" upper_limit="1.3"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 29</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="1.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" lower_limit="2.2" upper_limit="4.7"/>
                    <measurement group_id="O2" value="4.5" lower_limit="3.7" upper_limit="5.4"/>
                    <measurement group_id="O3" value="6.0" lower_limit="5.1" upper_limit="7.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="5.7" upper_limit="12.4"/>
                    <measurement group_id="O2" value="14.8" lower_limit="12.9" upper_limit="17.0"/>
                    <measurement group_id="O3" value="16.0" lower_limit="13.8" upper_limit="18.6"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="1.4" upper_limit="2.7"/>
                    <measurement group_id="O2" value="3.2" lower_limit="2.7" upper_limit="3.8"/>
                    <measurement group_id="O3" value="3.6" lower_limit="3.0" upper_limit="4.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="1.0" upper_limit="1.6"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.7" upper_limit="2.3"/>
                    <measurement group_id="O3" value="1.8" lower_limit="1.5" upper_limit="2.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.1" upper_limit="1.3"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 29</title>
              <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="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="3.2" upper_limit="7.8"/>
                    <measurement group_id="O2" value="6.0" lower_limit="5.0" upper_limit="7.3"/>
                    <measurement group_id="O3" value="7.9" lower_limit="6.4" upper_limit="9.7"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" lower_limit="8.6" upper_limit="17.0"/>
                    <measurement group_id="O2" value="14.7" lower_limit="12.7" upper_limit="16.9"/>
                    <measurement group_id="O3" value="16.6" lower_limit="14.0" upper_limit="19.6"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" lower_limit="1.6" upper_limit="3.6"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.6" upper_limit="3.5"/>
                    <measurement group_id="O3" value="3.6" lower_limit="3.0" upper_limit="4.3"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.2" upper_limit="2.2"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.5" upper_limit="2.1"/>
                    <measurement group_id="O3" value="2.0" lower_limit="1.6" upper_limit="2.4"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="1.0" upper_limit="1.4"/>
                    <measurement group_id="O2" value="1.3" lower_limit="1.2" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.4" lower_limit="1.2" upper_limit="1.6"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="1.5" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.7" lower_limit="2.3" upper_limit="3.2"/>
                    <measurement group_id="O3" value="3.5" lower_limit="2.9" upper_limit="4.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="3.5" upper_limit="8.5"/>
                    <measurement group_id="O2" value="8.6" lower_limit="7.5" upper_limit="9.8"/>
                    <measurement group_id="O3" value="10.2" lower_limit="8.6" upper_limit="12.0"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.1" upper_limit="2.1"/>
                    <measurement group_id="O2" value="2.3" lower_limit="2.0" upper_limit="2.7"/>
                    <measurement group_id="O3" value="2.6" lower_limit="2.2" upper_limit="3.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.9" upper_limit="1.5"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.4" upper_limit="2.0"/>
                    <measurement group_id="O3" value="1.7" lower_limit="1.4" upper_limit="2.0"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 365</title>
              <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="1.3" lower_limit="1.2" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.2" upper_limit="1.5"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 29</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 group_id="O3" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="1.5" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.8" lower_limit="2.4" upper_limit="3.3"/>
                    <measurement group_id="O3" value="4.0" lower_limit="3.3" upper_limit="4.8"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" lower_limit="3.8" upper_limit="8.7"/>
                    <measurement group_id="O2" value="9.0" lower_limit="7.8" upper_limit="10.3"/>
                    <measurement group_id="O3" value="10.8" lower_limit="9.1" upper_limit="12.8"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="1.0" upper_limit="1.7"/>
                    <measurement group_id="O2" value="2.1" lower_limit="1.8" upper_limit="2.4"/>
                    <measurement group_id="O3" value="2.7" lower_limit="2.3" upper_limit="3.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.9" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.4" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.6" lower_limit="1.4" upper_limit="2.0"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.1" upper_limit="1.3"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 29</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="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.4" upper_limit="2.8"/>
                    <measurement group_id="O2" value="2.6" lower_limit="2.2" upper_limit="3.1"/>
                    <measurement group_id="O3" value="3.4" lower_limit="2.8" upper_limit="4.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="3.6" upper_limit="8.3"/>
                    <measurement group_id="O2" value="9.1" lower_limit="7.9" upper_limit="10.4"/>
                    <measurement group_id="O3" value="10.6" lower_limit="9.0" upper_limit="12.5"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="1.1" upper_limit="1.9"/>
                    <measurement group_id="O2" value="2.3" lower_limit="2.0" upper_limit="2.6"/>
                    <measurement group_id="O3" value="2.5" lower_limit="2.2" upper_limit="3.0"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="1.0" upper_limit="1.5"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.5" upper_limit="2.0"/>
                    <measurement group_id="O3" value="1.7" lower_limit="1.4" upper_limit="2.0"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="1.0" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.2" upper_limit="1.5"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years</title>
        <description>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 50 - 65 years.&#xD;
Calculations are based on number of subjects with non-missing results.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <population>In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.</population>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years</title>
          <description>GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 50 - 65 years.&#xD;
Calculations are based on number of subjects with non-missing results.</description>
          <population>In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.</population>
          <units>Geometric Mean of the Fold Rise</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="0"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ST1 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.2" lower_limit="1.0" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.1" lower_limit="1.6" upper_limit="2.8"/>
                    <measurement group_id="O3" value="1.8" lower_limit="1.4" upper_limit="2.3"/>
                    <measurement group_id="O4" value="1.0" lower_limit="0.9" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.5" lower_limit="3.3" upper_limit="6.1"/>
                    <measurement group_id="O3" value="4.5" lower_limit="3.3" upper_limit="6.0"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.7" lower_limit="1.4" upper_limit="2.1"/>
                    <measurement group_id="O3" value="1.6" lower_limit="1.3" upper_limit="1.9"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.2" lower_limit="1.0" upper_limit="1.5"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.1" upper_limit="1.5"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST1 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.2" lower_limit="1.0" upper_limit="1.3"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="0.9" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.1" lower_limit="0.9" upper_limit="1.3"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.4" lower_limit="3.2" upper_limit="6.1"/>
                    <measurement group_id="O3" value="4.1" lower_limit="3.0" upper_limit="5.5"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="12.3" lower_limit="9.5" upper_limit="15.8"/>
                    <measurement group_id="O3" value="13.3" lower_limit="10.2" upper_limit="17.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.9" lower_limit="2.3" upper_limit="3.8"/>
                    <measurement group_id="O3" value="2.9" lower_limit="2.2" upper_limit="3.7"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.5" lower_limit="1.2" upper_limit="1.9"/>
                    <measurement group_id="O3" value="1.6" lower_limit="1.2" upper_limit="2.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST2 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.2" lower_limit="1.1" upper_limit="1.5"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.1" lower_limit="1.0" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.9" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6.1" lower_limit="4.3" upper_limit="8.7"/>
                    <measurement group_id="O3" value="5.9" lower_limit="4.3" upper_limit="8.2"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.9" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="12.5" lower_limit="9.6" upper_limit="16.4"/>
                    <measurement group_id="O3" value="12.8" lower_limit="9.7" upper_limit="17.0"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.9" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.3" lower_limit="2.6" upper_limit="4.2"/>
                    <measurement group_id="O3" value="3.0" lower_limit="2.3" upper_limit="3.8"/>
                    <measurement group_id="O4" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.7" lower_limit="1.3" upper_limit="2.2"/>
                    <measurement group_id="O3" value="1.8" lower_limit="1.4" upper_limit="2.5"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.9" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST3 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.3" lower_limit="1.1" upper_limit="1.5"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.9" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.1" lower_limit="0.9" upper_limit="1.3"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.7" lower_limit="2.0" upper_limit="3.7"/>
                    <measurement group_id="O3" value="2.6" lower_limit="2.0" upper_limit="3.3"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="7.4" lower_limit="5.7" upper_limit="9.7"/>
                    <measurement group_id="O3" value="7.9" lower_limit="6.1" upper_limit="10.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.2" lower_limit="1.8" upper_limit="2.8"/>
                    <measurement group_id="O3" value="2.1" lower_limit="1.7" upper_limit="2.5"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.4" lower_limit="1.2" upper_limit="1.7"/>
                    <measurement group_id="O3" value="1.4" lower_limit="1.1" upper_limit="1.7"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.9" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST4 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.2" lower_limit="1.0" upper_limit="1.4"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.3"/>
                    <measurement group_id="O4" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.1" lower_limit="0.9" upper_limit="1.2"/>
                    <measurement group_id="O3" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.9" lower_limit="2.1" upper_limit="3.8"/>
                    <measurement group_id="O3" value="2.8" lower_limit="2.1" upper_limit="3.6"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="7.8" lower_limit="5.9" upper_limit="10.3"/>
                    <measurement group_id="O3" value="8.1" lower_limit="6.2" upper_limit="10.6"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.2" lower_limit="1.8" upper_limit="2.8"/>
                    <measurement group_id="O3" value="2.0" lower_limit="1.6" upper_limit="2.6"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.4" lower_limit="1.2" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.5" lower_limit="1.2" upper_limit="1.9"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.9" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST5 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.1" lower_limit="1.0" upper_limit="1.3"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.1" lower_limit="0.9" upper_limit="1.2"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.6" lower_limit="1.9" upper_limit="3.4"/>
                    <measurement group_id="O3" value="2.6" lower_limit="2.0" upper_limit="3.4"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="7.9" lower_limit="6.1" upper_limit="10.4"/>
                    <measurement group_id="O3" value="8.7" lower_limit="6.7" upper_limit="11.3"/>
                    <measurement group_id="O4" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.3" lower_limit="1.9" upper_limit="2.9"/>
                    <measurement group_id="O3" value="2.3" lower_limit="1.8" upper_limit="2.9"/>
                    <measurement group_id="O4" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 236</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.4" lower_limit="1.1" upper_limit="1.7"/>
                    <measurement group_id="O3" value="1.5" lower_limit="1.2" upper_limit="1.9"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.9" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ST6 Day 365</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.2" lower_limit="1.0" upper_limit="1.3"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.3"/>
                    <measurement group_id="O4" value="1.1" lower_limit="1.0" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SAEs (Serious Adverse Events)</title>
        <description>Frequency of SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SAEs (Serious Adverse Events)</title>
          <description>Frequency of SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.</description>
          <units>percentage of participants</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="29"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="205"/>
                <count group_id="O4" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="1.9" lower_limit="0.7" upper_limit="4.7"/>
                    <measurement group_id="O3" value="2.4" lower_limit="1.0" upper_limit="5.6"/>
                    <measurement group_id="O4" value="2.4" lower_limit="0.8" upper_limit="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Related SAEs (Serious Adverse Events)</title>
        <description>Frequency of related SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Related SAEs (Serious Adverse Events)</title>
          <description>Frequency of related SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.</description>
          <units>percentage of participants</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="29"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="205"/>
                <count group_id="O4" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="1.8"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="1.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With AESIs (Adverse Events of Special Interest)</title>
        <description>Frequency of AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants.&#xD;
AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With AESIs (Adverse Events of Special Interest)</title>
          <description>Frequency of AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants.&#xD;
AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.</description>
          <units>percentage of participants</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="29"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="205"/>
                <count group_id="O4" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="1.9" lower_limit="0.7" upper_limit="4.7"/>
                    <measurement group_id="O3" value="0.5" lower_limit="0.1" upper_limit="2.7"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Related AESIs (Adverse Events of Special Interest)</title>
        <description>Frequency of related AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants.&#xD;
AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Related AESIs (Adverse Events of Special Interest)</title>
          <description>Frequency of related AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants.&#xD;
AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.</description>
          <units>percentage of participants</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="29"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="205"/>
                <count group_id="O4" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.1" upper_limit="2.6"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="1.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Unsolicited AEs (Adverse Events)</title>
        <description>Frequency of unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Unsolicited AEs (Adverse Events)</title>
          <description>Frequency of unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.</description>
          <units>percentage of participants</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="29"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="205"/>
                <count group_id="O4" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.6" lower_limit="14.7" upper_limit="45.7"/>
                    <measurement group_id="O2" value="51.9" lower_limit="45.2" upper_limit="58.5"/>
                    <measurement group_id="O3" value="56.6" lower_limit="49.7" upper_limit="63.2"/>
                    <measurement group_id="O4" value="51.6" lower_limit="42.9" upper_limit="60.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Related Unsolicited AEs (Adverse Events)</title>
        <description>Frequency of related unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Related Unsolicited AEs (Adverse Events)</title>
          <description>Frequency of related unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.</description>
          <units>percentage of participants</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="29"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="205"/>
                <count group_id="O4" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="1.9" upper_limit="22.0"/>
                    <measurement group_id="O2" value="9.3" lower_limit="6.1" upper_limit="14.0"/>
                    <measurement group_id="O3" value="14.6" lower_limit="10.4" upper_limit="20.1"/>
                    <measurement group_id="O4" value="8.9" lower_limit="5.0" upper_limit="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Solicited Local and Solicited Systemic AEs (Adverse Events)</title>
        <description>Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after each and after any vaccination; frequency is being assessed in terms of percentage of participants.</description>
        <time_frame>Day 1 (day of first vaccination) through Day 7; Day 29 (day of second vaccination) through Day 35; Day 57 (day of third vaccination) through Day 63</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Solicited Local and Solicited Systemic AEs (Adverse Events)</title>
          <description>Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after each and after any vaccination; frequency is being assessed in terms of percentage of participants.</description>
          <units>percentage of participants</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="29"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="205"/>
                <count group_id="O4" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Solicted Local AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.7" lower_limit="73.6" upper_limit="96.4"/>
                    <measurement group_id="O2" value="93.0" lower_limit="88.8" upper_limit="95.7"/>
                    <measurement group_id="O3" value="96.1" lower_limit="92.5" upper_limit="98.0"/>
                    <measurement group_id="O4" value="29.8" lower_limit="22.5" upper_limit="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Solicited Systemic AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.1" lower_limit="44.0" upper_limit="77.3"/>
                    <measurement group_id="O2" value="67.8" lower_limit="61.2" upper_limit="73.7"/>
                    <measurement group_id="O3" value="71.7" lower_limit="65.2" upper_limit="77.4"/>
                    <measurement group_id="O4" value="42.7" lower_limit="34.4" upper_limit="51.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 18-49</title>
        <description>Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), solicited and unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 18-49; frequency is being assessed in terms of percentage of participants.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <population>The overall number analyzed is for all participants. Below listed number of participants is for the different age groups.</population>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 18-49</title>
          <description>Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), solicited and unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 18-49; frequency is being assessed in terms of percentage of participants.</description>
          <population>The overall number analyzed is for all participants. Below listed number of participants is for the different age groups.</population>
          <units>percentage of participants</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="29"/>
                <count group_id="O2" value="147"/>
                <count group_id="O3" value="145"/>
                <count group_id="O4" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="2.0" lower_limit="0.7" upper_limit="5.8"/>
                    <measurement group_id="O3" value="2.1" lower_limit="0.7" upper_limit="5.9"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.2" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="11.7"/>
                    <measurement group_id="O2" value="0.7" lower_limit="0.1" upper_limit="3.8"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="2.6"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>solicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.7" lower_limit="73.6" upper_limit="96.4"/>
                    <measurement group_id="O2" value="93.9" lower_limit="88.8" upper_limit="96.7"/>
                    <measurement group_id="O3" value="96.6" lower_limit="92.2" upper_limit="98.5"/>
                    <measurement group_id="O4" value="56.0" lower_limit="45.8" upper_limit="65.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.6" lower_limit="14.7" upper_limit="45.7"/>
                    <measurement group_id="O2" value="49.0" lower_limit="41.0" upper_limit="57.0"/>
                    <measurement group_id="O3" value="55.2" lower_limit="47.0" upper_limit="63.0"/>
                    <measurement group_id="O4" value="50.5" lower_limit="40.5" upper_limit="60.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 50-65 Years</title>
        <description>Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 50-65 years; frequency is being assessed in terms of percentage of participants.</description>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <population>In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.</population>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 50-65 Years</title>
          <description>Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 50-65 years; frequency is being assessed in terms of percentage of participants.</description>
          <population>In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.</population>
          <units>percentage of participants</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="0"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.5" lower_limit="0.3" upper_limit="8.0"/>
                    <measurement group_id="O3" value="3.3" lower_limit="0.9" upper_limit="11.4"/>
                    <measurement group_id="O4" value="6.1" lower_limit="1.7" upper_limit="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.5" lower_limit="1.5" upper_limit="12.4"/>
                    <measurement group_id="O3" value="1.7" lower_limit="0.3" upper_limit="8.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>solicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="92.5" lower_limit="83.7" upper_limit="96.8"/>
                    <measurement group_id="O3" value="96.7" lower_limit="88.6" upper_limit="99.1"/>
                    <measurement group_id="O4" value="51.5" lower_limit="35.2" upper_limit="67.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="58.2" lower_limit="46.3" upper_limit="69.3"/>
                    <measurement group_id="O3" value="60.0" lower_limit="47.4" upper_limit="71.4"/>
                    <measurement group_id="O4" value="54.5" lower_limit="38.0" upper_limit="70.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End</title>
        <time_frame>up to Day 365 / Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VLA15 Low Dose</title>
            <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O2">
            <title>VLA15 Medium Dose</title>
            <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O3">
            <title>VLA15 High Dose</title>
            <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End</title>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="205"/>
                <count group_id="O4" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE of Special Interest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0."/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lyme disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema migrans</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Osteoarthritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polyarthritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to Day 365</time_frame>
      <desc>Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.</desc>
      <group_list>
        <group group_id="E1">
          <title>VLA15 Low Dose</title>
          <description>VLA15 low dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
        </group>
        <group group_id="E2">
          <title>VLA15 Medium Dose</title>
          <description>VLA15 medium dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
        </group>
        <group group_id="E3">
          <title>VLA15 High Dose</title>
          <description>VLA15 high dose with Alum.&#xD;
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Placebo: Placebo: PBS (Phosphate Buffered Saline)</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="205"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Neurosyphilis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Plasmacytoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="26" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="203" subjects_at_risk="214"/>
                <counts group_id="E3" subjects_affected="202" subjects_at_risk="205"/>
                <counts group_id="E4" subjects_affected="85" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E2" events="31" subjects_affected="23" subjects_at_risk="214"/>
                <counts group_id="E3" events="36" subjects_affected="32" subjects_at_risk="205"/>
                <counts group_id="E4" events="15" subjects_affected="11" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <description>includes systematic and non-systematic assessments</description>
                <counts group_id="E1" events="111" subjects_affected="26" subjects_at_risk="29"/>
                <counts group_id="E2" events="924" subjects_affected="198" subjects_at_risk="214"/>
                <counts group_id="E3" events="941" subjects_affected="196" subjects_at_risk="205"/>
                <counts group_id="E4" events="57" subjects_affected="30" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <description>includes systematic and non-systematic assessments</description>
                <counts group_id="E1" events="14" subjects_affected="8" subjects_at_risk="29"/>
                <counts group_id="E2" events="111" subjects_affected="66" subjects_at_risk="214"/>
                <counts group_id="E3" events="130" subjects_affected="81" subjects_at_risk="205"/>
                <counts group_id="E4" events="40" subjects_affected="29" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="29"/>
                <counts group_id="E2" events="116" subjects_affected="68" subjects_at_risk="214"/>
                <counts group_id="E3" events="123" subjects_affected="72" subjects_at_risk="205"/>
                <counts group_id="E4" events="18" subjects_affected="12" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="108" subjects_affected="64" subjects_at_risk="214"/>
                <counts group_id="E3" events="108" subjects_affected="65" subjects_at_risk="205"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E2" events="84" subjects_affected="57" subjects_at_risk="214"/>
                <counts group_id="E3" events="104" subjects_affected="68" subjects_at_risk="205"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <description>includes systematic and non-systematic assessments</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="44" subjects_affected="32" subjects_at_risk="214"/>
                <counts group_id="E3" events="49" subjects_affected="42" subjects_at_risk="205"/>
                <counts group_id="E4" events="25" subjects_affected="20" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="214"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="205"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="214"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="205"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="214"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="205"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <description>includes systematic and non-systematic assessments</description>
                <counts group_id="E1" events="22" subjects_affected="15" subjects_at_risk="29"/>
                <counts group_id="E2" events="173" subjects_affected="106" subjects_at_risk="214"/>
                <counts group_id="E3" events="156" subjects_affected="97" subjects_at_risk="205"/>
                <counts group_id="E4" events="29" subjects_affected="21" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <description>includes systematic and non-systematic assessments</description>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="67" subjects_affected="42" subjects_at_risk="214"/>
                <counts group_id="E3" events="55" subjects_affected="37" subjects_at_risk="205"/>
                <counts group_id="E4" events="23" subjects_affected="12" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>includes systematic and non-systematic assessments</description>
                <counts group_id="E1" events="19" subjects_affected="10" subjects_at_risk="29"/>
                <counts group_id="E2" events="115" subjects_affected="73" subjects_at_risk="214"/>
                <counts group_id="E3" events="135" subjects_affected="84" subjects_at_risk="205"/>
                <counts group_id="E4" events="46" subjects_affected="33" subjects_at_risk="124"/>
              </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>Director Clinical Strategy</name_or_title>
      <organization>Valneva Austria GmbH</organization>
      <phone>+43120620 ext 0</phone>
      <email>office@valneva.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/NCT03769194
org study id: VLA15-201
nct id: NCT03769194
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study conducted
      in two study phases: a run-in phase and a main study phase. The study was investigated 3
      doses of a multivalent OspA (Outer Surface Protein A) based Lyme vaccine (VLA15) in healthy
      adults aged 18 to 65 years of age. Study participants received 3 immunizations of the vaccine
      at a monthly interval. The study assessed the immune response as well as the safety profile
      of the vaccine.
This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study.

      In the Run-in phase, a total of 120 subjects aged 18 to 40 years were randomized 1:1:1:1 to
      receive one of three VLA15 doses (VLA15 low dose (90 µg), VLA15 medium dose (135 µg), VLA15
      high dose (180 µg)) or Placebo as intramuscular vaccinations on Days 1, 29 and 57.

      Dosing was adjusted by injection volume.

      In the Main Study phase, a total of 452 subjects aged 18 to 65 years were randomized 2:2:1 to
      receive VLA15 135 µg or VLA15 180 µg, the two dose groups were selected from the Run-in-Phase
      or placebo, as intramuscular vaccinations on Days 1, 29 and 57. Subjects were enrolled in two
      age groups (18-49 years and 50-65 years) in a ratio of approx. 2:1.

      In both study phases, target was to enroll approx. 10 % or more of subjects that were
      baseline seropositive for Borrelia burgdorferi sensu latu (Bb s.l.).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6
time frame: at Day 85 / Month 3
description: GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85.
GMTs are calculated based on the number of subjects with non-missing results.
measure: GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
time frame: up to Day 365 / Month 12
description: GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA.
GMTs are calculated based on the number of subjects with non-missing results.
measure: SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
time frame: up to Day 365 / Month 12
description: Seroconversion for ELISA is defined as:
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a certain time point.
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.
Percentages are based on the number of subjects with non-missing observations.
measure: GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
time frame: up to Day 365 / Month 12
description: GMFR (Geometric Mean of the Fold Rise as compared to baseline) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA.
Calculations are based on number of subjects with non-missing results.
measure: GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
time frame: up to Day 365 / Month 12
description: GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 18 - 49 years.
GMTs are calculated based on the number of subjects with non-missing results.
measure: GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
time frame: up to Day 365 / Month 12
description: GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 50 - 65 years.
GMTs are calculated based on the number of subjects with non-missing results.
measure: SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
time frame: up to Day 365 / Month 12
description: SCRs (Seroconversion Rate) for Seroconversion for ELISA is defined as:
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point.
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.
Percentages are based on the number of subjects with non-missing observations.
measure: SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
time frame: up to Day 365 / Month 12
description: Seroconversion for ELISA is defined as:
for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point.
for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.
Percentages are based on the number of subjects with non-missing observations.
measure: GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
time frame: up to Day 365 / Month 12
description: GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 18 - 49 years.
Calculations are based on number of subjects with non-missing results.
measure: GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
time frame: up to Day 365 / Month 12
description: GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 50 - 65 years.
Calculations are based on number of subjects with non-missing results.
measure: Percentage of Participants With SAEs (Serious Adverse Events)
time frame: up to Day 365 / Month 12
description: Frequency of SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.
measure: Percentage of Participants With Related SAEs (Serious Adverse Events)
time frame: up to Day 365 / Month 12
description: Frequency of related SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.
measure: Percentage of Participants With AESIs (Adverse Events of Special Interest)
time frame: up to Day 365 / Month 12
description: Frequency of AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants.
AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.
measure: Percentage of Participants With Related AESIs (Adverse Events of Special Interest)
time frame: up to Day 365 / Month 12
description: Frequency of related AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants.
AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.
measure: Percentage of Participants With Unsolicited AEs (Adverse Events)
time frame: up to Day 365 / Month 12
description: Frequency of unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.
measure: Percentage of Participants With Related Unsolicited AEs (Adverse Events)
time frame: up to Day 365 / Month 12
description: Frequency of related unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.
measure: Percentage of Participants With Solicited Local and Solicited Systemic AEs (Adverse Events)
time frame: Day 1 (day of first vaccination) through Day 7; Day 29 (day of second vaccination) through Day 35; Day 57 (day of third vaccination) through Day 63
description: Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after each and after any vaccination; frequency is being assessed in terms of percentage of participants.
measure: Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 18-49
time frame: up to Day 365 / Month 12
description: Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), solicited and unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 18-49; frequency is being assessed in terms of percentage of participants.
measure: Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 50-65 Years
time frame: up to Day 365 / Month 12
description: Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 50-65 years; frequency is being assessed in terms of percentage of participants.
measure: Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End
time frame: up to Day 365 / Month 12
arm group label: VLA15 low dose
arm group type: Active Comparator
description: VLA15 low dose with Alum.
arm group label: VLA15 medium dose
arm group type: Active Comparator
description: VLA15 medium dose with Alum.
arm group label: VLA15 high dose
arm group type: Active Comparator
description: VLA15 high dose with Alum.
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Biological
intervention name: VLA15
description: a multivalent recombinant Outer surface protein A (OspA) based vaccine candidate
arm group label: VLA15 high dose
arm group label: VLA15 low dose
arm group label: VLA15 medium dose
intervention type: Biological
intervention name: Placebo
description: Placebo: PBS (Phosphate Buffered Saline)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Germany
country: United States
responsible party type: Sponsor
mesh term: Borrelia Infections
mesh term: Lyme Disease
provided document: 
provided document: 
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 