<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/NCT03807245</url>
  </required_header>
  <id_info>
    <org_study_id>2017-003871-27</org_study_id>
    <nct_id>NCT03807245</nct_id>
  </id_info>
  <brief_title>Group B Streptococcus Vaccine in Healthy Females</brief_title>
  <acronym>MVX0002</acronym>
  <official_title>A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Group B Streptococcus Vaccine (GBS-NN/NN2 With Alhydrogel®) in Healthy Female Subjects Aged 18 to 40</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minervax ApS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Simbec Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Minervax ApS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study&#xD;
      to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus&#xD;
      vaccine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There will be 4 arms in 2 cohorts of 30 subjects. Cohort 1 will receive two 0.5 mL&#xD;
      injections, 4 weeks apart, each consisting of 25 μg of GBS-NN and 25 μg of GBS-NN2 (24&#xD;
      subjects) or placebo (6 subjects). Cohort 2 (30 subjects) will receive two 0.5 mL injections,&#xD;
      4 weeks apart, each consisting of 50 μg of GBS-NN and 50 μg of GBS-NN2 (24 subjects) or&#xD;
      placebo (6 Subjects). All vaccines will be adsorbed to 500 μg Al3+ as Alhydrogel®.&#xD;
&#xD;
      Safety will be assessed after all subjects have completed Visit 4 (Day 8) for Cohort 1, at&#xD;
      which point the decision will be made as to whether proceeding with administration of the&#xD;
      doses in cohort 2 is appropriate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Actual">May 7, 2020</completion_date>
  <primary_completion_date type="Actual">October 14, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events</measure>
    <time_frame>85 days</time_frame>
    <description>Number of Participants with Treatment Emergent Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunoglobulin(Ig)G Antibody Concentration</measure>
    <time_frame>Day 85</time_frame>
    <description>Adjusted geometric mean concentration (GMC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fold Change in Antibody Concentration</measure>
    <time_frame>Day 1 to Day 85</time_frame>
    <description>Geometric mean fold change in antibody concentration from Day 1 to Day 85 for each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion Rate</measure>
    <time_frame>Day 85</time_frame>
    <description>4-fold increase in Immunoglobulin(Ig)G antibody concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Immune Response to First and Second Doses</measure>
    <time_frame>Day 29 and Day 85</time_frame>
    <description>Number of participants with Immunoglobulin(Ig)G antibody concentration above thresholds</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Group B Strep Infection</condition>
  <arm_group>
    <arm_group_label>GBS-NN/NN2 with Alhydrogel® 25</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GBS-NN/NN2 with Alhydrogel® 25 mcg intramuscular 2 times with 4 weeks apart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo GBS-NN/NN2 with Alhydrogel® 25</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GBS-NN/NN2 with Alhydrogel® 50</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intramuscular GBS-NN/NN2 with Alhydrogel® injection 50 mcg 2 times with 4 weeks apart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo GBS-NN/NN2 with Alhydrogel® 50</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GBS-NN/NN2 with Alhydrogel® 25</intervention_name>
    <description>GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart</description>
    <arm_group_label>GBS-NN/NN2 with Alhydrogel® 25</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo GBS-NN/NN2 with Alhydrogel® 25</intervention_name>
    <description>GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart</description>
    <arm_group_label>Placebo GBS-NN/NN2 with Alhydrogel® 25</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo GBS-NN/NN2 with Alhydrogel® 50</intervention_name>
    <description>GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart</description>
    <arm_group_label>Placebo GBS-NN/NN2 with Alhydrogel® 50</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GBS-NN/NN2 with Alhydrogel® 50</intervention_name>
    <description>GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart</description>
    <arm_group_label>GBS-NN/NN2 with Alhydrogel® 50</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy female subjects aged 18 - 40 years.&#xD;
&#xD;
          2. Body mass index (BMI) ≥18 and ≤30 kg/m2.&#xD;
&#xD;
          3. Subjects weight ≥50kg and ≤100kg at screening.&#xD;
&#xD;
          4. Able to voluntarily provide written informed consent to participate in the study.&#xD;
&#xD;
          5. Subjects are pre-menopausal.&#xD;
&#xD;
          6. Females of childbearing potential must have a negative pregnancy test at screening (β&#xD;
             HCG) and prior to each dose. To prevent pregnancy female subjects of childbearing&#xD;
             potential must take adequate contraceptive precautions for the entire duration of&#xD;
             study participation (up to Day 85). Adequate and highly effective contraceptive&#xD;
             precautions include:&#xD;
&#xD;
               -  Established use of oral, injected or implanted hormonal methods of contraception.&#xD;
&#xD;
               -  Placement of an intrauterine device (IUD) or intrauterine system (IUS).&#xD;
&#xD;
               -  Barrier methods of contraception: Condom or occlusive cap (diaphragm or&#xD;
                  cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.&#xD;
&#xD;
               -  Male sterilisation (with the appropriate post-vasectomy documentation of the&#xD;
                  absence of sperm in the ejaculate). [For female subjects, the vasectomised male&#xD;
                  partner should be the sole partner for that subject].&#xD;
&#xD;
               -  True abstinence, when this is in line with the preferred and usual lifestyle of&#xD;
                  the subject.&#xD;
&#xD;
             [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation&#xD;
             methods) and withdrawal are not acceptable methods of contraception].&#xD;
&#xD;
             • The chosen contraception method(s) must be followed from the first dose until at&#xD;
             least Day 85 of the study.&#xD;
&#xD;
          7. Non-smokers for at least 3 months prior to first study vaccine administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have received GBS-NN vaccine previously.&#xD;
&#xD;
          2. Subjects with history or presence of significant cardiovascular disease, pulmonary,&#xD;
             hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal,&#xD;
             endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease&#xD;
             or current infection.&#xD;
&#xD;
          3. Pregnant or lactating females.&#xD;
&#xD;
          4. Laboratory values at screening which are deemed by the investigator to be clinically&#xD;
             significantly abnormal.&#xD;
&#xD;
          5. Positive drug screen for drugs of abuse or a positive alcohol urine test prior to&#xD;
             first dosing unless there is a documented medical explanation for the positive result&#xD;
             other than drugs of abuse (e.g., the subject has been prescribed opioids for pain).&#xD;
&#xD;
          6. Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.&#xD;
&#xD;
          7. Participation in a clinical drug study during the 90 days preceding the initial dose&#xD;
             in this study.&#xD;
&#xD;
          8. Any significant illness during the 4 weeks preceding check-in for this study (Day 1).&#xD;
&#xD;
          9. Subjects with a history of allergic reactions after previous vaccination.&#xD;
&#xD;
         10. Subjects who have received any vaccine within 30 days of screening, or who are&#xD;
             planning to receive a vaccine up to Day 85 of the study.&#xD;
&#xD;
         11. Subjects receiving immunosuppressive therapy in the 6 months prior to screening,&#xD;
             taking any short-term medications including over-the-counter (OTC) preparations,&#xD;
             within 7 days of the first dose. Chronic medications such as antihypertensives,&#xD;
             bronchodilators, oral contraceptives or statins that do not affect the immune system,&#xD;
             will be permitted and allowed to continue during the study at the discretion of the&#xD;
             Investigator. Paracetamol will be permitted for the treatment of headache or other&#xD;
             symptoms. Use of OTC vitamins and dietary supplements is allowed&#xD;
&#xD;
         12. Subjects with tattoos at the proposed site of vaccine administration.&#xD;
&#xD;
         13. Donation of blood or blood products within 90 days prior to vaccine administration or&#xD;
             intending to donate blood or blood products within 90 days of the last visit.&#xD;
&#xD;
         14. Subjects who, in the opinion of the Investigator, are unsuitable for participation in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geoff Kitson</last_name>
    <role>Study Director</role>
    <affiliation>gkitson@propharmapartners.uk.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Simbec Research Limited</name>
      <address>
        <city>Merthyr Tydfil</city>
        <state>Wales</state>
        <zip>CF48 4DR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <results_first_submitted>November 30, 2020</results_first_submitted>
  <results_first_submitted_qc>November 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 24, 2020</results_first_posted>
  <last_update_submitted>January 30, 2021</last_update_submitted>
  <last_update_submitted_qc>January 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Streptococcal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aluminum Hydroxide</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03807245/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Healthy female participants aged 18 to 40 years were recruited in a Phase 1 unit from January 2019 and the study was completed by October 2019.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>GBS-NN/NN2 With Alhydrogel® 25</title>
          <description>GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
        </group>
        <group group_id="P2">
          <title>GBS-NN/NN2 With Alhydrogel® 50</title>
          <description>GBS-NN/NN2 with Alhydrogel® containing 50 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
        </group>
        <group group_id="P3">
          <title>Placebo With Alhydrogel®</title>
          <description>Placebo (buffer with Alhydrogel®) vaccine administered by intramuscular injection 2 times with 4 weeks apart</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GBS-NN/NN2 With Alhydrogel® 25</title>
          <description>GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
        </group>
        <group group_id="B2">
          <title>GBS-NN/NN2 With Alhydrogel® 50</title>
          <description>GBS-NN/NN2 with Alhydrogel® containing 50 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
        </group>
        <group group_id="B3">
          <title>Placebo With Alhydrogel®</title>
          <description>Placebo (buffer with Alhydrogel®) vaccine administered by intramuscular injection 2 times with 4 weeks apart</description>
        </group>
        <group group_id="B4">
          <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="24"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="60"/>
          </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="29.8" spread="5.36"/>
                    <measurement group_id="B2" value="30.8" spread="6.04"/>
                    <measurement group_id="B3" value="27.3" spread="5.53"/>
                    <measurement group_id="B4" value="29.7" spread="5.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Healthy females</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events</title>
        <description>Number of Participants with Treatment Emergent Adverse Events</description>
        <time_frame>85 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GBS-NN/NN2 With Alhydrogel® 25</title>
            <description>GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
          <group group_id="O2">
            <title>GBS-NN/NN2 With Alhydrogel® 50</title>
            <description>GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
          <group group_id="O3">
            <title>Placebo With Alhydrogel®</title>
            <description>Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events</title>
          <description>Number of Participants with Treatment Emergent Adverse Events</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunoglobulin(Ig)G Antibody Concentration</title>
        <description>Adjusted geometric mean concentration (GMC)</description>
        <time_frame>Day 85</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GBS-NN/NN2 With Alhydrogel® 25</title>
            <description>GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
          <group group_id="O2">
            <title>GBS-NN/NN2 With Alhydrogel® 50</title>
            <description>GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
          <group group_id="O3">
            <title>Placebo With Alhydrogel®</title>
            <description>Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
        </group_list>
        <measure>
          <title>Immunoglobulin(Ig)G Antibody Concentration</title>
          <description>Adjusted geometric mean concentration (GMC)</description>
          <units>Adjusted GMC mcg/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="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GBS-NN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" lower_limit="11.1" upper_limit="20.8"/>
                    <measurement group_id="O2" value="17.1" lower_limit="12.5" upper_limit="23.4"/>
                    <measurement group_id="O3" value="0.115" lower_limit="0.0746" upper_limit="0.177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="18.8" upper_limit="30.8"/>
                    <measurement group_id="O2" value="29.9" lower_limit="23.4" upper_limit="38.3"/>
                    <measurement group_id="O3" value="0.154" lower_limit="0.109" upper_limit="0.216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fold Change in Antibody Concentration</title>
        <description>Geometric mean fold change in antibody concentration from Day 1 to Day 85 for each group.</description>
        <time_frame>Day 1 to Day 85</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GBS-NN/NN2 With Alhydrogel® 25</title>
            <description>GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
          <group group_id="O2">
            <title>GBS-NN/NN2 With Alhydrogel® 50</title>
            <description>GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
          <group group_id="O3">
            <title>Placebo With Alhydrogel®</title>
            <description>Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
        </group_list>
        <measure>
          <title>Fold Change in Antibody Concentration</title>
          <description>Geometric mean fold change in antibody concentration from Day 1 to Day 85 for each group.</description>
          <units>Fold change from Day 1 to Day 85</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="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GBS-NN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127.707" lower_limit="79.310" upper_limit="205.637"/>
                    <measurement group_id="O2" value="131.526" lower_limit="93.987" upper_limit="184.057"/>
                    <measurement group_id="O3" value="0.951" lower_limit="0.791" upper_limit="1.144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169.594" lower_limit="104.224" upper_limit="275.964"/>
                    <measurement group_id="O2" value="211.303" lower_limit="140.290" upper_limit="318.260"/>
                    <measurement group_id="O3" value="0.946" lower_limit="0.838" upper_limit="1.068"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 25mcg/placebo</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 50mcg/placebo</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroconversion Rate</title>
        <description>4-fold increase in Immunoglobulin(Ig)G antibody concentration</description>
        <time_frame>Day 85</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GBS-NN/NN2 With Alhydrogel® 25</title>
            <description>GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
          <group group_id="O2">
            <title>GBS-NN/NN2 With Alhydrogel® 50</title>
            <description>GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
          <group group_id="O3">
            <title>Placebo With Alhydrogel®</title>
            <description>Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Rate</title>
          <description>4-fold increase in Immunoglobulin(Ig)G antibody concentration</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GBS-NN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Immune Response to First and Second Doses</title>
        <description>Number of participants with Immunoglobulin(Ig)G antibody concentration above thresholds</description>
        <time_frame>Day 29 and Day 85</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GBS-NN/NN2 With Alhydrogel® 25</title>
            <description>GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
          <group group_id="O2">
            <title>GBS-NN/NN2 With Alhydrogel® 50</title>
            <description>GBS-NN/NN2 with Alhydrogel® containing 50mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
          <group group_id="O3">
            <title>Placebo With Alhydrogel®</title>
            <description>Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Immune Response to First and Second Doses</title>
          <description>Number of participants with Immunoglobulin(Ig)G antibody concentration above thresholds</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GBS-NN Day 29 increase above 1mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN Day 29 increase above 2mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN Day 29 increase above 4mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN Day 29 increase above 8mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN Day 85 increase above 1mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN Day 85 increase above 2mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN Day 85 increase above 4mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN Day 85 increase above 8mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2 Day 29 increase above 1mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2 Day 29 increase above 2mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2 Day 29 increase above 4mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2 Day 29 increase above 8mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2 Day 85 increase above 1mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2 Day 85 increase above 2mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2 Day 85 increase above 4mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GBS-NN2 Day 85 increase above 8mcg/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>85 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>GBS-NN/NN2 With Alhydrogel® 25</title>
          <description>GBS-NN/NN2 with Alhydrogel® containing 25 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
        </group>
        <group group_id="E2">
          <title>GBS-NN/NN2 With Alhydrogel® 50</title>
          <description>GBS-NN/NN2 with Alhydrogel® containing 50 mcg of each GBS-NN and GBS-NN2 administered by intramuscular injection 2 times with 4 weeks apart</description>
        </group>
        <group group_id="E3">
          <title>Placebo With Alhydrogel®</title>
          <description>Placebo (buffer with Alhydrogel®) administered by intramuscular injection 2 times with 4 weeks apart</description>
        </group>
      </group_list>
      <serious_events>
        <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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>Medra 22.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to animal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Post-traumatic neck syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hypomenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </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 NOT 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>Dr Per Fischer</name_or_title>
      <organization>MinervaX ApS</organization>
      <phone>+45 20 25 20 38</phone>
      <email>pbf@minervax.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/NCT03807245
org study id: 2017-003871-27
nct id: NCT03807245
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study
      to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus
      vaccine.
There will be 4 arms in 2 cohorts of 30 subjects. Cohort 1 will receive two 0.5 mL
      injections, 4 weeks apart, each consisting of 25 μg of GBS-NN and 25 μg of GBS-NN2 (24
      subjects) or placebo (6 subjects). Cohort 2 (30 subjects) will receive two 0.5 mL injections,
      4 weeks apart, each consisting of 50 μg of GBS-NN and 50 μg of GBS-NN2 (24 subjects) or
      placebo (6 Subjects). All vaccines will be adsorbed to 500 μg Al3+ as Alhydrogel®.

      Safety will be assessed after all subjects have completed Visit 4 (Day 8) for Cohort 1, at
      which point the decision will be made as to whether proceeding with administration of the
      doses in cohort 2 is appropriate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Participants With Treatment Emergent Adverse Events
time frame: 85 days
description: Number of Participants with Treatment Emergent Adverse Events
measure: Immunoglobulin(Ig)G Antibody Concentration
time frame: Day 85
description: Adjusted geometric mean concentration (GMC)
measure: Fold Change in Antibody Concentration
time frame: Day 1 to Day 85
description: Geometric mean fold change in antibody concentration from Day 1 to Day 85 for each group.
measure: Seroconversion Rate
time frame: Day 85
description: 4-fold increase in Immunoglobulin(Ig)G antibody concentration
measure: Number of Participants With an Immune Response to First and Second Doses
time frame: Day 29 and Day 85
description: Number of participants with Immunoglobulin(Ig)G antibody concentration above thresholds
arm group label: GBS-NN/NN2 with Alhydrogel® 25
arm group type: Experimental
description: GBS-NN/NN2 with Alhydrogel® 25 mcg intramuscular 2 times with 4 weeks apart
arm group label: Placebo GBS-NN/NN2 with Alhydrogel® 25
arm group type: Placebo Comparator
description: Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart
arm group label: GBS-NN/NN2 with Alhydrogel® 50
arm group type: Experimental
description: Intramuscular GBS-NN/NN2 with Alhydrogel® injection 50 mcg 2 times with 4 weeks apart
arm group label: Placebo GBS-NN/NN2 with Alhydrogel® 50
arm group type: Placebo Comparator
description: Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart
intervention type: Biological
intervention name: GBS-NN/NN2 with Alhydrogel® 25
description: GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
arm group label: GBS-NN/NN2 with Alhydrogel® 25
intervention type: Biological
intervention name: Placebo GBS-NN/NN2 with Alhydrogel® 25
description: GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
arm group label: Placebo GBS-NN/NN2 with Alhydrogel® 25
intervention type: Biological
intervention name: Placebo GBS-NN/NN2 with Alhydrogel® 50
description: GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
arm group label: Placebo GBS-NN/NN2 with Alhydrogel® 50
intervention type: Biological
intervention name: GBS-NN/NN2 with Alhydrogel® 50
description: GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
arm group label: GBS-NN/NN2 with Alhydrogel® 50
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Geoff Kitson
role: Study Director
affiliation: gkitson@propharmapartners.uk.com
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Streptococcal Infections
mesh term: Aluminum Hydroxide
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 