<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/NCT03039790</url>
  </required_header>
  <id_info>
    <org_study_id>NOR-213</org_study_id>
    <secondary_id>2016-004288-37</secondary_id>
    <secondary_id>U1111-1189-7907</secondary_id>
    <nct_id>NCT03039790</nct_id>
  </id_info>
  <brief_title>Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults</brief_title>
  <official_title>A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects Who Have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate descriptively the long-term immunogenicity of at&#xD;
      least 1 NoV vaccine administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Results prepared and posted by Takeda on behalf of Hillevax, the IND holder.&#xD;
&#xD;
      The drug being tested in this study is called NoV vaccine. NoV vaccine is being tested for&#xD;
      protection against acute gastroenteritis (AGE) due to norovirus.&#xD;
&#xD;
      The study will enroll maximum of approximately 575 participants. Participants who previously&#xD;
      received NoV vaccine in studies NOR-107, NOR-210 and NOR-204 will be enrolled. Participants&#xD;
      from study NOR-107 will enter the study at the time of their 3rd year post-primary&#xD;
      vaccination, and from studies NOR-210 and NOR-204, at their 2nd year post-primary&#xD;
      vaccination. The duration of participation in the study will be different for each&#xD;
      participant.&#xD;
&#xD;
      This multi-center trial will be conducted in Belgium and the United States. The overall time&#xD;
      to participate in this study is maximum 5 years after primary NoV vaccination. Participants&#xD;
      will have a maximum of 4 visits over 3 years&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">July 22, 2021</completion_date>
  <primary_completion_date type="Actual">July 22, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay</measure>
    <time_frame>Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study</time_frame>
    <description>GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204) , at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107, NOR-210, NOR-204)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay</measure>
    <time_frame>Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study</time_frame>
    <description>GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3 4 and 5 (NOR-107,NOR-210, NOR-204) .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)</measure>
    <time_frame>Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study</time_frame>
    <description>GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA). Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5(NOR-107,NOR-210, NOR-204).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA</measure>
    <time_frame>Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study</time_frame>
    <description>GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. Data reported for up to Year 5 was collected at Baseline (NOR-107,NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107,NOR-210, NOR-204).</description>
  </secondary_outcome>
  <number_of_arms>20</number_of_arms>
  <enrollment type="Actual">528</enrollment>
  <condition>Healthy Volunteers</condition>
  <condition>Norovirus</condition>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants who received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminium hydroxide, IM on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 yrs)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 yrs)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NoV Vaccine</intervention_name>
    <description>NoV vaccine injection administered.</description>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose</arm_group_label>
    <arm_group_label>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose</arm_group_label>
    <arm_group_label>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose</arm_group_label>
    <arm_group_label>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 yrs)</arm_group_label>
    <arm_group_label>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 yrs)</arm_group_label>
    <arm_group_label>NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose</arm_group_label>
    <arm_group_label>NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Male and female participants who previously received at least 1 dose of NoV vaccine in&#xD;
        trials NOR-107 (NCT02038907), NOR-210 (NCT02475278) and NOR-204 (NCT02661490), have&#xD;
        baseline and post-vaccination data, and completed the primary vaccination trial protocol as&#xD;
        initially described.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in any clinical trial is allowed, on condition that no investigational&#xD;
             product is administered within 30 days prior to blood sampling.&#xD;
&#xD;
          2. In the opinion of the investigator, the participant is not medically eligible to&#xD;
             provide blood specimens.&#xD;
&#xD;
          3. Individuals with behavioral or cognitive impairment or psychiatric disease that, in&#xD;
             the opinion of the investigator, may interfere with the participant's ability to&#xD;
             participate in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Simon-Williamson Clinic/Synexus Clinical Research US, Inc</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.</name>
      <address>
        <city>Fountain Hills</city>
        <state>Arizona</state>
        <zip>85268</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc/Southwest Family Medicine</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Research Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johnson County Clin-Trials</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis University, School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63106</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>13760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universiteit Antwerpen</name>
      <address>
        <city>Antwerpen</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>July 21, 2022</results_first_submitted>
  <results_first_submitted_qc>September 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 6, 2022</results_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <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>March 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03039790/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>September 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03039790/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P2">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P3">
          <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P4">
          <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P5">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P6">
          <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P7">
          <title>NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P8">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P9">
          <title>NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P10">
          <title>NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P11">
          <title>NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P12">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose</title>
          <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P13">
          <title>NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose</title>
          <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P14">
          <title>NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose</title>
          <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P15">
          <title>NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose</title>
          <description>Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P16">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose</title>
          <description>Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P17">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)</title>
          <description>Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P18">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)</title>
          <description>Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P19">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose</title>
          <description>Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="P20">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose</title>
          <description>Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="27"/>
                <participants group_id="P5" count="23"/>
                <participants group_id="P6" count="27"/>
                <participants group_id="P7" count="25"/>
                <participants group_id="P8" count="28"/>
                <participants group_id="P9" count="22"/>
                <participants group_id="P10" count="28"/>
                <participants group_id="P11" count="21"/>
                <participants group_id="P12" count="25"/>
                <participants group_id="P13" count="24"/>
                <participants group_id="P14" count="24"/>
                <participants group_id="P15" count="24"/>
                <participants group_id="P16" count="29"/>
                <participants group_id="P17" count="39"/>
                <participants group_id="P18" count="14"/>
                <participants group_id="P19" count="35"/>
                <participants group_id="P20" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per Protocol Set (PPS)</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="26"/>
                <participants group_id="P5" count="23"/>
                <participants group_id="P6" count="27"/>
                <participants group_id="P7" count="25"/>
                <participants group_id="P8" count="28"/>
                <participants group_id="P9" count="22"/>
                <participants group_id="P10" count="28"/>
                <participants group_id="P11" count="19"/>
                <participants group_id="P12" count="25"/>
                <participants group_id="P13" count="24"/>
                <participants group_id="P14" count="24"/>
                <participants group_id="P15" count="24"/>
                <participants group_id="P16" count="29"/>
                <participants group_id="P17" count="39"/>
                <participants group_id="P18" count="14"/>
                <participants group_id="P19" count="35"/>
                <participants group_id="P20" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="25"/>
                <participants group_id="P5" count="23"/>
                <participants group_id="P6" count="26"/>
                <participants group_id="P7" count="24"/>
                <participants group_id="P8" count="27"/>
                <participants group_id="P9" count="22"/>
                <participants group_id="P10" count="26"/>
                <participants group_id="P11" count="20"/>
                <participants group_id="P12" count="25"/>
                <participants group_id="P13" count="21"/>
                <participants group_id="P14" count="24"/>
                <participants group_id="P15" count="20"/>
                <participants group_id="P16" count="22"/>
                <participants group_id="P17" count="29"/>
                <participants group_id="P18" count="12"/>
                <participants group_id="P19" count="29"/>
                <participants group_id="P20" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="3"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="4"/>
                <participants group_id="P16" count="7"/>
                <participants group_id="P17" count="10"/>
                <participants group_id="P18" count="2"/>
                <participants group_id="P19" count="6"/>
                <participants group_id="P20" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="3"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="2"/>
                <participants group_id="P18" count="2"/>
                <participants group_id="P19" count="1"/>
                <participants group_id="P20" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of Consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="2"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="5"/>
                <participants group_id="P17" count="3"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="2"/>
                <participants group_id="P20" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="3"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="2"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason, not Specified</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="2"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="1"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS) included all participants with data from at least 1 follow-up time point.</population>
      <group_list>
        <group group_id="B1">
          <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B2">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B3">
          <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B4">
          <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B5">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B6">
          <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B7">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B8">
          <title>NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B9">
          <title>NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B10">
          <title>NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B11">
          <title>NOR-107: GI.1/GII.4 (15/150/167) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B12">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose</title>
          <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B13">
          <title>NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose</title>
          <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B14">
          <title>NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose</title>
          <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B15">
          <title>NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose</title>
          <description>Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B16">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose</title>
          <description>Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B17">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)</title>
          <description>Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B18">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)</title>
          <description>Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B19">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose</title>
          <description>Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B20">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose</title>
          <description>Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="B21">
          <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="25"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="27"/>
            <count group_id="B4" value="27"/>
            <count group_id="B5" value="23"/>
            <count group_id="B6" value="27"/>
            <count group_id="B7" value="25"/>
            <count group_id="B8" value="28"/>
            <count group_id="B9" value="22"/>
            <count group_id="B10" value="28"/>
            <count group_id="B11" value="21"/>
            <count group_id="B12" value="25"/>
            <count group_id="B13" value="24"/>
            <count group_id="B14" value="24"/>
            <count group_id="B15" value="24"/>
            <count group_id="B16" value="29"/>
            <count group_id="B17" value="39"/>
            <count group_id="B18" value="14"/>
            <count group_id="B19" value="35"/>
            <count group_id="B20" value="42"/>
            <count group_id="B21" value="528"/>
          </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="48.1" spread="14.24"/>
                    <measurement group_id="B2" value="47.9" spread="14.60"/>
                    <measurement group_id="B3" value="46.8" spread="13.39"/>
                    <measurement group_id="B4" value="47.5" spread="13.96"/>
                    <measurement group_id="B5" value="48.0" spread="13.49"/>
                    <measurement group_id="B6" value="48.0" spread="13.13"/>
                    <measurement group_id="B7" value="45.4" spread="13.63"/>
                    <measurement group_id="B8" value="46.8" spread="13.59"/>
                    <measurement group_id="B9" value="45.5" spread="13.23"/>
                    <measurement group_id="B10" value="44.0" spread="15.20"/>
                    <measurement group_id="B11" value="41.9" spread="16.17"/>
                    <measurement group_id="B12" value="42.6" spread="13.33"/>
                    <measurement group_id="B13" value="47.3" spread="13.98"/>
                    <measurement group_id="B14" value="46.3" spread="15.17"/>
                    <measurement group_id="B15" value="35.0" spread="9.44"/>
                    <measurement group_id="B16" value="73.6" spread="8.50"/>
                    <measurement group_id="B17" value="77.2" spread="9.48"/>
                    <measurement group_id="B18" value="35.6" spread="7.27"/>
                    <measurement group_id="B19" value="76.9" spread="9.94"/>
                    <measurement group_id="B20" value="76.1" spread="8.41"/>
                    <measurement group_id="B21" value="53.6" spread="18.82"/>
                  </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="13"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="21"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="14"/>
                    <measurement group_id="B9" value="16"/>
                    <measurement group_id="B10" value="21"/>
                    <measurement group_id="B11" value="12"/>
                    <measurement group_id="B12" value="15"/>
                    <measurement group_id="B13" value="18"/>
                    <measurement group_id="B14" value="16"/>
                    <measurement group_id="B15" value="10"/>
                    <measurement group_id="B16" value="20"/>
                    <measurement group_id="B17" value="19"/>
                    <measurement group_id="B18" value="7"/>
                    <measurement group_id="B19" value="18"/>
                    <measurement group_id="B20" value="23"/>
                    <measurement group_id="B21" value="324"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="13"/>
                    <measurement group_id="B8" value="14"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="7"/>
                    <measurement group_id="B11" value="9"/>
                    <measurement group_id="B12" value="10"/>
                    <measurement group_id="B13" value="6"/>
                    <measurement group_id="B14" value="8"/>
                    <measurement group_id="B15" value="14"/>
                    <measurement group_id="B16" value="9"/>
                    <measurement group_id="B17" value="20"/>
                    <measurement group_id="B18" value="7"/>
                    <measurement group_id="B19" value="17"/>
                    <measurement group_id="B20" value="19"/>
                    <measurement group_id="B21" value="204"/>
                  </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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="5"/>
                    <measurement group_id="B16" value="1"/>
                    <measurement group_id="B17" value="2"/>
                    <measurement group_id="B18" value="1"/>
                    <measurement group_id="B19" value="3"/>
                    <measurement group_id="B20" value="3"/>
                    <measurement group_id="B21" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not 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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="19"/>
                    <measurement group_id="B16" value="28"/>
                    <measurement group_id="B17" value="37"/>
                    <measurement group_id="B18" value="13"/>
                    <measurement group_id="B19" value="32"/>
                    <measurement group_id="B20" value="39"/>
                    <measurement group_id="B21" value="168"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="27"/>
                    <measurement group_id="B7" value="25"/>
                    <measurement group_id="B8" value="28"/>
                    <measurement group_id="B9" value="22"/>
                    <measurement group_id="B10" value="28"/>
                    <measurement group_id="B11" value="21"/>
                    <measurement group_id="B12" value="25"/>
                    <measurement group_id="B13" value="24"/>
                    <measurement group_id="B14" value="24"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                    <measurement group_id="B21" value="345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                    <measurement group_id="B21" 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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="1"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                    <measurement group_id="B21" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="1"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                    <measurement group_id="B21" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="7"/>
                    <measurement group_id="B16" value="1"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="1"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="3"/>
                    <measurement group_id="B21" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="26"/>
                    <measurement group_id="B7" value="25"/>
                    <measurement group_id="B8" value="28"/>
                    <measurement group_id="B9" value="22"/>
                    <measurement group_id="B10" value="27"/>
                    <measurement group_id="B11" value="21"/>
                    <measurement group_id="B12" value="25"/>
                    <measurement group_id="B13" value="24"/>
                    <measurement group_id="B14" value="24"/>
                    <measurement group_id="B15" value="16"/>
                    <measurement group_id="B16" value="28"/>
                    <measurement group_id="B17" value="38"/>
                    <measurement group_id="B18" value="12"/>
                    <measurement group_id="B19" value="35"/>
                    <measurement group_id="B20" value="39"/>
                    <measurement group_id="B21" value="510"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="1"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                    <measurement group_id="B21" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                    <measurement group_id="B21" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="27"/>
                    <measurement group_id="B7" value="25"/>
                    <measurement group_id="B8" value="28"/>
                    <measurement group_id="B9" value="22"/>
                    <measurement group_id="B10" value="28"/>
                    <measurement group_id="B11" value="21"/>
                    <measurement group_id="B12" value="25"/>
                    <measurement group_id="B13" value="24"/>
                    <measurement group_id="B14" value="24"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                    <measurement group_id="B21" value="345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="24"/>
                    <measurement group_id="B16" value="29"/>
                    <measurement group_id="B17" value="39"/>
                    <measurement group_id="B18" value="14"/>
                    <measurement group_id="B19" value="35"/>
                    <measurement group_id="B20" value="42"/>
                    <measurement group_id="B21" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay</title>
        <description>GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204) , at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107, NOR-210, NOR-204)</description>
        <time_frame>Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study</time_frame>
        <population>Per Protocol Set (PPS) included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O2">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O3">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O4">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O5">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O6">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O7">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O8">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O9">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O10">
            <title>NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O11">
            <title>NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O12">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose</title>
            <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O13">
            <title>NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose</title>
            <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O14">
            <title>NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose</title>
            <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O15">
            <title>NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose</title>
            <description>Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O16">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose</title>
            <description>Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O17">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)</title>
            <description>Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O18">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)</title>
            <description>Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O19">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose</title>
            <description>Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O20">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose</title>
            <description>Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay</title>
          <description>GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204) , at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107, NOR-210, NOR-204)</description>
          <population>Per Protocol Set (PPS) included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="26"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="27"/>
                <count group_id="O7" value="25"/>
                <count group_id="O8" value="28"/>
                <count group_id="O9" value="22"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="19"/>
                <count group_id="O12" value="25"/>
                <count group_id="O13" value="24"/>
                <count group_id="O14" value="24"/>
                <count group_id="O15" value="24"/>
                <count group_id="O16" value="29"/>
                <count group_id="O17" value="39"/>
                <count group_id="O18" value="14"/>
                <count group_id="O19" value="35"/>
                <count group_id="O20" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.4" lower_limit="17.5" upper_limit="42.9"/>
                    <measurement group_id="O2" value="18.3" lower_limit="13.4" upper_limit="24.9"/>
                    <measurement group_id="O3" value="26.3" lower_limit="17.4" upper_limit="39.6"/>
                    <measurement group_id="O4" value="24.6" lower_limit="15.5" upper_limit="38.9"/>
                    <measurement group_id="O5" value="19.0" lower_limit="15.5" upper_limit="23.2"/>
                    <measurement group_id="O6" value="23.9" lower_limit="17.2" upper_limit="33.2"/>
                    <measurement group_id="O7" value="35.1" lower_limit="21.7" upper_limit="56.9"/>
                    <measurement group_id="O8" value="24.3" lower_limit="16.5" upper_limit="35.8"/>
                    <measurement group_id="O9" value="26.1" lower_limit="16.8" upper_limit="40.5"/>
                    <measurement group_id="O10" value="23.9" lower_limit="17.5" upper_limit="32.7"/>
                    <measurement group_id="O11" value="33.4" lower_limit="19.4" upper_limit="57.6"/>
                    <measurement group_id="O12" value="23.1" lower_limit="16.4" upper_limit="32.6"/>
                    <measurement group_id="O13" value="22.9" lower_limit="15.9" upper_limit="32.9"/>
                    <measurement group_id="O14" value="21.3" lower_limit="15.4" upper_limit="29.3"/>
                    <measurement group_id="O15" value="19.0" lower_limit="14.1" upper_limit="25.6"/>
                    <measurement group_id="O16" value="20.8" lower_limit="16.4" upper_limit="26.3"/>
                    <measurement group_id="O17" value="28.9" lower_limit="20.7" upper_limit="40.5"/>
                    <measurement group_id="O18" value="18.7" lower_limit="13.0" upper_limit="26.9"/>
                    <measurement group_id="O19" value="23.9" lower_limit="18.5" upper_limit="30.8"/>
                    <measurement group_id="O20" value="26.4" lower_limit="19.4" upper_limit="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="21"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" lower_limit="18.2" upper_limit="42.2"/>
                    <measurement group_id="O2" value="18.1" lower_limit="13.2" upper_limit="24.8"/>
                    <measurement group_id="O3" value="23.8" lower_limit="16.4" upper_limit="34.5"/>
                    <measurement group_id="O4" value="24.0" lower_limit="15.4" upper_limit="37.3"/>
                    <measurement group_id="O5" value="17.4" lower_limit="14.5" upper_limit="20.9"/>
                    <measurement group_id="O6" value="21.9" lower_limit="16.1" upper_limit="29.9"/>
                    <measurement group_id="O7" value="29.9" lower_limit="20.2" upper_limit="44.2"/>
                    <measurement group_id="O8" value="24.9" lower_limit="17.2" upper_limit="36.1"/>
                    <measurement group_id="O9" value="27.3" lower_limit="17.2" upper_limit="43.4"/>
                    <measurement group_id="O10" value="25.8" lower_limit="18.3" upper_limit="36.3"/>
                    <measurement group_id="O11" value="34.9" lower_limit="20.8" upper_limit="58.5"/>
                    <measurement group_id="O12" value="382.6" lower_limit="200.9" upper_limit="728.5"/>
                    <measurement group_id="O13" value="338.0" lower_limit="196.7" upper_limit="580.7"/>
                    <measurement group_id="O14" value="449.4" lower_limit="270.5" upper_limit="746.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O15" value="212.5" lower_limit="129.9" upper_limit="347.5"/>
                    <measurement group_id="O16" value="21.3" lower_limit="16.9" upper_limit="26.9"/>
                    <measurement group_id="O17" value="28.7" lower_limit="20.6" upper_limit="40.0"/>
                    <measurement group_id="O18" value="19.9" lower_limit="13.5" upper_limit="29.2"/>
                    <measurement group_id="O19" value="342.5" lower_limit="206.3" upper_limit="568.5"/>
                    <measurement group_id="O20" value="329.2" lower_limit="213.3" upper_limit="508.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="263.3" lower_limit="143.3" upper_limit="483.9"/>
                    <measurement group_id="O17" value="213.4" lower_limit="117.2" upper_limit="388.5"/>
                    <measurement group_id="O18" value="155.3" lower_limit="51.5" upper_limit="468.2"/>
                    <measurement group_id="O19" value="406.4" lower_limit="274.6" upper_limit="601.4"/>
                    <measurement group_id="O20" value="307.2" lower_limit="206.1" upper_limit="458.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="309.7" lower_limit="168.7" upper_limit="568.4"/>
                    <measurement group_id="O2" value="256.9" lower_limit="136.3" upper_limit="484.0"/>
                    <measurement group_id="O3" value="380.9" lower_limit="227.0" upper_limit="639.2"/>
                    <measurement group_id="O4" value="255.4" lower_limit="132.3" upper_limit="493.1"/>
                    <measurement group_id="O5" value="252.9" lower_limit="136.7" upper_limit="468.1"/>
                    <measurement group_id="O6" value="329.2" lower_limit="192.9" upper_limit="561.9"/>
                    <measurement group_id="O7" value="369.5" lower_limit="221.0" upper_limit="617.8"/>
                    <measurement group_id="O8" value="350.4" lower_limit="194.5" upper_limit="631.2"/>
                    <measurement group_id="O9" value="527.0" lower_limit="264.1" upper_limit="1051.5"/>
                    <measurement group_id="O10" value="274.3" lower_limit="171.6" upper_limit="438.4"/>
                    <measurement group_id="O11" value="315.8" lower_limit="154.5" upper_limit="645.2"/>
                    <measurement group_id="O12" value="435.9" lower_limit="288.8" upper_limit="658.0"/>
                    <measurement group_id="O13" value="427.6" lower_limit="300.0" upper_limit="609.6"/>
                    <measurement group_id="O14" value="377.4" lower_limit="251.6" upper_limit="566.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="228.9" lower_limit="136.4" upper_limit="384.1"/>
                    <measurement group_id="O17" value="223.0" lower_limit="133.9" upper_limit="371.5"/>
                    <measurement group_id="O18" value="105.1" lower_limit="40.9" upper_limit="270.5"/>
                    <measurement group_id="O19" value="362.5" lower_limit="255.9" upper_limit="513.5"/>
                    <measurement group_id="O20" value="304.3" lower_limit="215.6" upper_limit="429.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 208</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143.5" lower_limit="84.7" upper_limit="243.2"/>
                    <measurement group_id="O2" value="109.1" lower_limit="62.9" upper_limit="189.1"/>
                    <measurement group_id="O3" value="154.8" lower_limit="95.7" upper_limit="250.4"/>
                    <measurement group_id="O4" value="125.6" lower_limit="74.9" upper_limit="210.8"/>
                    <measurement group_id="O5" value="86.4" lower_limit="50.5" upper_limit="148.1"/>
                    <measurement group_id="O6" value="137.9" lower_limit="93.7" upper_limit="202.8"/>
                    <measurement group_id="O7" value="168.9" lower_limit="109.1" upper_limit="261.5"/>
                    <measurement group_id="O8" value="175.4" lower_limit="111.6" upper_limit="275.6"/>
                    <measurement group_id="O9" value="214.1" lower_limit="120.7" upper_limit="379.6"/>
                    <measurement group_id="O10" value="125.3" lower_limit="83.7" upper_limit="187.6"/>
                    <measurement group_id="O11" value="115.3" lower_limit="61.5" upper_limit="216.0"/>
                    <measurement group_id="O12" value="208.7" lower_limit="134.0" upper_limit="324.9"/>
                    <measurement group_id="O13" value="201.5" lower_limit="141.3" upper_limit="287.4"/>
                    <measurement group_id="O14" value="185.6" lower_limit="126.9" upper_limit="271.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="115.9" lower_limit="72.1" upper_limit="186.4"/>
                    <measurement group_id="O17" value="96.5" lower_limit="62.6" upper_limit="148.7"/>
                    <measurement group_id="O18" value="43.4" lower_limit="20.1" upper_limit="93.9"/>
                    <measurement group_id="O19" value="132.9" lower_limit="89.2" upper_limit="198.0"/>
                    <measurement group_id="O20" value="126.6" lower_limit="85.6" upper_limit="187.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="26"/>
                    <count group_id="O17" value="37"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="32"/>
                    <count group_id="O20" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O15" value="48.8" lower_limit="31.2" upper_limit="76.4"/>
                    <measurement group_id="O16" value="46.3" lower_limit="30.7" upper_limit="69.8"/>
                    <measurement group_id="O17" value="63.6" lower_limit="39.6" upper_limit="102.1"/>
                    <measurement group_id="O18" value="38.9" lower_limit="16.7" upper_limit="90.6"/>
                    <measurement group_id="O19" value="58.9" lower_limit="39.8" upper_limit="87.2"/>
                    <measurement group_id="O20" value="83.4" lower_limit="58.2" upper_limit="119.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="26"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="27"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="21"/>
                    <count group_id="O16" value="24"/>
                    <count group_id="O17" value="35"/>
                    <count group_id="O18" value="13"/>
                    <count group_id="O19" value="29"/>
                    <count group_id="O20" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.6" lower_limit="48.9" upper_limit="129.7"/>
                    <measurement group_id="O2" value="53.7" lower_limit="32.8" upper_limit="88.0"/>
                    <measurement group_id="O3" value="77.2" lower_limit="49.1" upper_limit="121.3"/>
                    <measurement group_id="O4" value="72.4" lower_limit="44.0" upper_limit="119.1"/>
                    <measurement group_id="O5" value="51.5" lower_limit="33.1" upper_limit="80.1"/>
                    <measurement group_id="O6" value="55.5" lower_limit="35.4" upper_limit="86.8"/>
                    <measurement group_id="O7" value="98.0" lower_limit="65.1" upper_limit="147.5"/>
                    <measurement group_id="O8" value="90.2" lower_limit="60.1" upper_limit="135.5"/>
                    <measurement group_id="O9" value="102.2" lower_limit="56.4" upper_limit="185.0"/>
                    <measurement group_id="O10" value="61.8" lower_limit="40.5" upper_limit="94.3"/>
                    <measurement group_id="O11" value="67.2" lower_limit="34.5" upper_limit="131.1"/>
                    <measurement group_id="O12" value="90.5" lower_limit="55.4" upper_limit="147.6"/>
                    <measurement group_id="O13" value="84.9" lower_limit="53.1" upper_limit="135.6"/>
                    <measurement group_id="O14" value="85.7" lower_limit="55.9" upper_limit="131.4"/>
                    <measurement group_id="O15" value="48.2" lower_limit="29.0" upper_limit="80.1"/>
                    <measurement group_id="O16" value="48.8" lower_limit="30.3" upper_limit="78.8"/>
                    <measurement group_id="O17" value="60.7" lower_limit="37.2" upper_limit="98.9"/>
                    <measurement group_id="O18" value="34.0" lower_limit="16.6" upper_limit="69.9"/>
                    <measurement group_id="O19" value="72.5" lower_limit="47.3" upper_limit="111.2"/>
                    <measurement group_id="O20" value="76.1" lower_limit="51.0" upper_limit="113.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="26"/>
                    <count group_id="O7" value="23"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="23"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="20"/>
                    <count group_id="O16" value="18"/>
                    <count group_id="O17" value="22"/>
                    <count group_id="O18" value="11"/>
                    <count group_id="O19" value="20"/>
                    <count group_id="O20" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.5" lower_limit="38.0" upper_limit="130.9"/>
                    <measurement group_id="O2" value="47.5" lower_limit="27.3" upper_limit="82.7"/>
                    <measurement group_id="O3" value="68.6" lower_limit="38.6" upper_limit="122.0"/>
                    <measurement group_id="O4" value="54.0" lower_limit="30.4" upper_limit="96.1"/>
                    <measurement group_id="O5" value="54.8" lower_limit="30.2" upper_limit="99.7"/>
                    <measurement group_id="O6" value="49.3" lower_limit="31.5" upper_limit="77.2"/>
                    <measurement group_id="O7" value="84.9" lower_limit="49.6" upper_limit="145.2"/>
                    <measurement group_id="O8" value="67.3" lower_limit="41.1" upper_limit="109.9"/>
                    <measurement group_id="O9" value="78.2" lower_limit="41.9" upper_limit="146.1"/>
                    <measurement group_id="O10" value="45.5" lower_limit="30.0" upper_limit="68.9"/>
                    <measurement group_id="O11" value="61.2" lower_limit="30.9" upper_limit="121.0"/>
                    <measurement group_id="O12" value="85.8" lower_limit="57.9" upper_limit="127.0"/>
                    <measurement group_id="O13" value="65.1" lower_limit="39.0" upper_limit="108.8"/>
                    <measurement group_id="O14" value="67.2" lower_limit="42.9" upper_limit="105.2"/>
                    <measurement group_id="O15" value="63.8" lower_limit="35.0" upper_limit="116.2"/>
                    <measurement group_id="O16" value="28.6" lower_limit="17.3" upper_limit="47.2"/>
                    <measurement group_id="O17" value="45.9" lower_limit="25.0" upper_limit="84.3"/>
                    <measurement group_id="O18" value="28.3" lower_limit="14.2" upper_limit="56.2"/>
                    <measurement group_id="O19" value="76.1" lower_limit="45.6" upper_limit="127.2"/>
                    <measurement group_id="O20" value="57.1" lower_limit="34.5" upper_limit="94.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="24"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="26"/>
                    <count group_id="O7" value="24"/>
                    <count group_id="O8" value="27"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="25"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="24"/>
                    <count group_id="O13" value="21"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="19"/>
                    <count group_id="O16" value="8"/>
                    <count group_id="O17" value="13"/>
                    <count group_id="O18" value="10"/>
                    <count group_id="O19" value="10"/>
                    <count group_id="O20" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0" lower_limit="37.8" upper_limit="133.6"/>
                    <measurement group_id="O2" value="42.5" lower_limit="25.0" upper_limit="72.4"/>
                    <measurement group_id="O3" value="80.5" lower_limit="45.0" upper_limit="144.0"/>
                    <measurement group_id="O4" value="54.4" lower_limit="30.8" upper_limit="96.2"/>
                    <measurement group_id="O5" value="50.5" lower_limit="28.7" upper_limit="89.1"/>
                    <measurement group_id="O6" value="54.5" lower_limit="31.0" upper_limit="96.0"/>
                    <measurement group_id="O7" value="77.2" lower_limit="48.4" upper_limit="123.1"/>
                    <measurement group_id="O8" value="82.2" lower_limit="49.0" upper_limit="137.7"/>
                    <measurement group_id="O9" value="80.9" lower_limit="43.3" upper_limit="151.1"/>
                    <measurement group_id="O10" value="54.1" lower_limit="32.6" upper_limit="89.7"/>
                    <measurement group_id="O11" value="62.0" lower_limit="32.5" upper_limit="118.5"/>
                    <measurement group_id="O12" value="82.1" lower_limit="50.9" upper_limit="132.4"/>
                    <measurement group_id="O13" value="69.1" lower_limit="42.3" upper_limit="112.6"/>
                    <measurement group_id="O14" value="74.9" lower_limit="49.1" upper_limit="114.2"/>
                    <measurement group_id="O15" value="52.8" lower_limit="28.6" upper_limit="97.4"/>
                    <measurement group_id="O16" value="34.7" lower_limit="15.8" upper_limit="76.1"/>
                    <measurement group_id="O17" value="41.9" lower_limit="21.8" upper_limit="80.3"/>
                    <measurement group_id="O18" value="31.9" lower_limit="14.6" upper_limit="69.6"/>
                    <measurement group_id="O19" value="59.8" lower_limit="29.0" upper_limit="123.2"/>
                    <measurement group_id="O20" value="65.5" lower_limit="37.9" upper_limit="113.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay</title>
        <description>GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3 4 and 5 (NOR-107,NOR-210, NOR-204) .</description>
        <time_frame>Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study</time_frame>
        <population>PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O2">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O3">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O4">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O5">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible participants who received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O6">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O7">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O8">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O9">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O10">
            <title>NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O11">
            <title>NOR-107: GI.1/GII.4 (15/15/167) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O12">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg,2-Dose</title>
            <description>Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O13">
            <title>NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose</title>
            <description>Eligible participants who received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O14">
            <title>NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose</title>
            <description>Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O15">
            <title>NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose</title>
            <description>Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O16">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose</title>
            <description>Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O17">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)</title>
            <description>Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O18">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)</title>
            <description>Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O19">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose</title>
            <description>Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O20">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose</title>
            <description>Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay</title>
          <description>GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3 4 and 5 (NOR-107,NOR-210, NOR-204) .</description>
          <population>PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="26"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="27"/>
                <count group_id="O7" value="25"/>
                <count group_id="O8" value="28"/>
                <count group_id="O9" value="22"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="19"/>
                <count group_id="O12" value="25"/>
                <count group_id="O13" value="24"/>
                <count group_id="O14" value="24"/>
                <count group_id="O15" value="24"/>
                <count group_id="O16" value="29"/>
                <count group_id="O17" value="39"/>
                <count group_id="O18" value="14"/>
                <count group_id="O19" value="35"/>
                <count group_id="O20" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.8" lower_limit="38.1" upper_limit="147.0"/>
                    <measurement group_id="O2" value="77.4" lower_limit="41.9" upper_limit="142.8"/>
                    <measurement group_id="O3" value="116.8" lower_limit="65.9" upper_limit="207.2"/>
                    <measurement group_id="O4" value="72.1" lower_limit="41.6" upper_limit="125.1"/>
                    <measurement group_id="O5" value="54.6" lower_limit="30.7" upper_limit="97.3"/>
                    <measurement group_id="O6" value="104.2" lower_limit="60.4" upper_limit="179.8"/>
                    <measurement group_id="O7" value="77.5" lower_limit="42.5" upper_limit="141.6"/>
                    <measurement group_id="O8" value="86.3" lower_limit="47.9" upper_limit="155.3"/>
                    <measurement group_id="O9" value="97.1" lower_limit="55.8" upper_limit="169.0"/>
                    <measurement group_id="O10" value="106.1" lower_limit="66.7" upper_limit="168.8"/>
                    <measurement group_id="O11" value="124.3" lower_limit="69.0" upper_limit="223.9"/>
                    <measurement group_id="O12" value="65.8" lower_limit="39.6" upper_limit="109.1"/>
                    <measurement group_id="O13" value="97.2" lower_limit="53.8" upper_limit="175.9"/>
                    <measurement group_id="O14" value="127.3" lower_limit="70.2" upper_limit="231.0"/>
                    <measurement group_id="O15" value="42.7" lower_limit="25.6" upper_limit="71.1"/>
                    <measurement group_id="O16" value="140.5" lower_limit="78.5" upper_limit="251.6"/>
                    <measurement group_id="O17" value="71.8" lower_limit="45.7" upper_limit="113.0"/>
                    <measurement group_id="O18" value="97.5" lower_limit="40.3" upper_limit="235.8"/>
                    <measurement group_id="O19" value="104.9" lower_limit="64.2" upper_limit="171.5"/>
                    <measurement group_id="O20" value="111.0" lower_limit="72.0" upper_limit="171.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="21"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.7" lower_limit="42.3" upper_limit="153.9"/>
                    <measurement group_id="O2" value="67.2" lower_limit="35.2" upper_limit="128.0"/>
                    <measurement group_id="O3" value="128.0" lower_limit="73.3" upper_limit="223.7"/>
                    <measurement group_id="O4" value="71.3" lower_limit="42.2" upper_limit="120.7"/>
                    <measurement group_id="O5" value="64.9" lower_limit="36.6" upper_limit="115.3"/>
                    <measurement group_id="O6" value="101.3" lower_limit="57.1" upper_limit="179.6"/>
                    <measurement group_id="O7" value="69.7" lower_limit="40.2" upper_limit="120.9"/>
                    <measurement group_id="O8" value="95.2" lower_limit="49.6" upper_limit="182.6"/>
                    <measurement group_id="O9" value="84.1" lower_limit="46.7" upper_limit="151.3"/>
                    <measurement group_id="O10" value="129.9" lower_limit="83.4" upper_limit="202.4"/>
                    <measurement group_id="O11" value="112.4" lower_limit="63.0" upper_limit="200.5"/>
                    <measurement group_id="O12" value="607.7" lower_limit="379.2" upper_limit="974.0"/>
                    <measurement group_id="O13" value="668.3" lower_limit="397.3" upper_limit="1124.0"/>
                    <measurement group_id="O14" value="893.6" lower_limit="578.4" upper_limit="1380.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O15" value="665.9" lower_limit="408.2" upper_limit="1086.2"/>
                    <measurement group_id="O16" value="118.3" lower_limit="66.7" upper_limit="210.0"/>
                    <measurement group_id="O17" value="63.5" lower_limit="41.0" upper_limit="98.4"/>
                    <measurement group_id="O18" value="83.2" lower_limit="34.3" upper_limit="201.9"/>
                    <measurement group_id="O19" value="1134.4" lower_limit="784.6" upper_limit="1640.1"/>
                    <measurement group_id="O20" value="824.2" lower_limit="493.4" upper_limit="1376.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="920.9" lower_limit="521.8" upper_limit="1625.4"/>
                    <measurement group_id="O17" value="518.7" lower_limit="273.0" upper_limit="985.2"/>
                    <measurement group_id="O18" value="1037.4" lower_limit="448.1" upper_limit="2401.9"/>
                    <measurement group_id="O19" value="1016.2" lower_limit="719.4" upper_limit="1435.4"/>
                    <measurement group_id="O20" value="766.8" lower_limit="483.1" upper_limit="1216.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="367.9" lower_limit="214.8" upper_limit="630.3"/>
                    <measurement group_id="O2" value="755.9" lower_limit="425.6" upper_limit="1342.6"/>
                    <measurement group_id="O3" value="425.1" lower_limit="298.8" upper_limit="604.8"/>
                    <measurement group_id="O4" value="277.9" lower_limit="178.2" upper_limit="433.4"/>
                    <measurement group_id="O5" value="584.7" lower_limit="367.5" upper_limit="930.1"/>
                    <measurement group_id="O6" value="593.4" lower_limit="436.2" upper_limit="807.2"/>
                    <measurement group_id="O7" value="201.9" lower_limit="110.6" upper_limit="368.4"/>
                    <measurement group_id="O8" value="810.0" lower_limit="507.4" upper_limit="1293.2"/>
                    <measurement group_id="O9" value="328.5" lower_limit="173.8" upper_limit="620.8"/>
                    <measurement group_id="O10" value="886.3" lower_limit="562.3" upper_limit="1397.0"/>
                    <measurement group_id="O11" value="746.6" lower_limit="456.8" upper_limit="1220.3"/>
                    <measurement group_id="O12" value="458.4" lower_limit="290.9" upper_limit="722.3"/>
                    <measurement group_id="O13" value="575.5" lower_limit="358.1" upper_limit="924.8"/>
                    <measurement group_id="O14" value="594.2" lower_limit="369.2" upper_limit="956.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="1133.2" lower_limit="682.7" upper_limit="1881.0"/>
                    <measurement group_id="O17" value="471.8" lower_limit="285.2" upper_limit="780.5"/>
                    <measurement group_id="O18" value="663.8" lower_limit="304.5" upper_limit="1447.1"/>
                    <measurement group_id="O19" value="740.2" lower_limit="549.0" upper_limit="998.0"/>
                    <measurement group_id="O20" value="589.1" lower_limit="359.7" upper_limit="964.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 208</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216.4" lower_limit="132.8" upper_limit="352.6"/>
                    <measurement group_id="O2" value="290.1" lower_limit="182.7" upper_limit="460.7"/>
                    <measurement group_id="O3" value="231.4" lower_limit="152.0" upper_limit="352.4"/>
                    <measurement group_id="O4" value="176.2" lower_limit="116.1" upper_limit="267.4"/>
                    <measurement group_id="O5" value="215.9" lower_limit="132.1" upper_limit="353.1"/>
                    <measurement group_id="O6" value="247.4" lower_limit="166.6" upper_limit="367.3"/>
                    <measurement group_id="O7" value="150.4" lower_limit="87.4" upper_limit="258.6"/>
                    <measurement group_id="O8" value="333.2" lower_limit="217.9" upper_limit="509.4"/>
                    <measurement group_id="O9" value="173.0" lower_limit="94.8" upper_limit="315.8"/>
                    <measurement group_id="O10" value="352.9" lower_limit="242.4" upper_limit="513.8"/>
                    <measurement group_id="O11" value="274.9" lower_limit="151.4" upper_limit="499.2"/>
                    <measurement group_id="O12" value="277.2" lower_limit="186.5" upper_limit="412.0"/>
                    <measurement group_id="O13" value="342.5" lower_limit="233.2" upper_limit="503.1"/>
                    <measurement group_id="O14" value="308.7" lower_limit="198.5" upper_limit="480.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="417.6" lower_limit="252.8" upper_limit="689.6"/>
                    <measurement group_id="O17" value="195.2" lower_limit="120.2" upper_limit="316.8"/>
                    <measurement group_id="O18" value="274.7" lower_limit="135.3" upper_limit="557.8"/>
                    <measurement group_id="O19" value="374.7" lower_limit="262.6" upper_limit="534.6"/>
                    <measurement group_id="O20" value="265.3" lower_limit="157.4" upper_limit="447.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="26"/>
                    <count group_id="O17" value="37"/>
                    <count group_id="O18" value="10"/>
                    <count group_id="O19" value="32"/>
                    <count group_id="O20" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O15" value="105.2" lower_limit="58.7" upper_limit="188.3"/>
                    <measurement group_id="O16" value="223.2" lower_limit="120.7" upper_limit="412.9"/>
                    <measurement group_id="O17" value="122.5" lower_limit="74.8" upper_limit="200.5"/>
                    <measurement group_id="O18" value="250.5" lower_limit="80.8" upper_limit="776.7"/>
                    <measurement group_id="O19" value="220.9" lower_limit="137.2" upper_limit="355.7"/>
                    <measurement group_id="O20" value="243.0" lower_limit="149.6" upper_limit="394.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="27"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="21"/>
                    <count group_id="O16" value="24"/>
                    <count group_id="O17" value="35"/>
                    <count group_id="O18" value="13"/>
                    <count group_id="O19" value="29"/>
                    <count group_id="O20" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122.7" lower_limit="65.7" upper_limit="229.2"/>
                    <measurement group_id="O2" value="177.1" lower_limit="96.8" upper_limit="323.9"/>
                    <measurement group_id="O3" value="117.9" lower_limit="69.6" upper_limit="199.7"/>
                    <measurement group_id="O4" value="104.0" lower_limit="60.2" upper_limit="179.6"/>
                    <measurement group_id="O5" value="80.5" lower_limit="45.4" upper_limit="142.9"/>
                    <measurement group_id="O6" value="125.9" lower_limit="74.7" upper_limit="212.3"/>
                    <measurement group_id="O7" value="121.2" lower_limit="71.1" upper_limit="206.7"/>
                    <measurement group_id="O8" value="164.1" lower_limit="97.7" upper_limit="275.5"/>
                    <measurement group_id="O9" value="125.3" lower_limit="67.9" upper_limit="230.9"/>
                    <measurement group_id="O10" value="167.0" lower_limit="111.3" upper_limit="250.4"/>
                    <measurement group_id="O11" value="142.2" lower_limit="76.9" upper_limit="263.1"/>
                    <measurement group_id="O12" value="149.2" lower_limit="83.1" upper_limit="267.9"/>
                    <measurement group_id="O13" value="144.7" lower_limit="83.1" upper_limit="251.7"/>
                    <measurement group_id="O14" value="173.8" lower_limit="104.6" upper_limit="288.8"/>
                    <measurement group_id="O15" value="87.5" lower_limit="43.9" upper_limit="174.5"/>
                    <measurement group_id="O16" value="172.0" lower_limit="100.1" upper_limit="295.5"/>
                    <measurement group_id="O17" value="94.9" lower_limit="59.4" upper_limit="151.3"/>
                    <measurement group_id="O18" value="133.8" lower_limit="56.2" upper_limit="318.9"/>
                    <measurement group_id="O19" value="153.3" lower_limit="100.1" upper_limit="234.8"/>
                    <measurement group_id="O20" value="162.4" lower_limit="102.5" upper_limit="257.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="26"/>
                    <count group_id="O7" value="23"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="23"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="20"/>
                    <count group_id="O16" value="18"/>
                    <count group_id="O17" value="22"/>
                    <count group_id="O18" value="11"/>
                    <count group_id="O19" value="20"/>
                    <count group_id="O20" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.7" lower_limit="46.7" upper_limit="157.1"/>
                    <measurement group_id="O2" value="122.8" lower_limit="67.4" upper_limit="223.6"/>
                    <measurement group_id="O3" value="90.8" lower_limit="54.4" upper_limit="151.3"/>
                    <measurement group_id="O4" value="79.5" lower_limit="48.3" upper_limit="130.8"/>
                    <measurement group_id="O5" value="61.7" lower_limit="35.7" upper_limit="106.5"/>
                    <measurement group_id="O6" value="106.7" lower_limit="64.7" upper_limit="176.1"/>
                    <measurement group_id="O7" value="108.6" lower_limit="62.0" upper_limit="190.3"/>
                    <measurement group_id="O8" value="131.2" lower_limit="81.9" upper_limit="210.2"/>
                    <measurement group_id="O9" value="101.9" lower_limit="60.1" upper_limit="172.7"/>
                    <measurement group_id="O10" value="113.9" lower_limit="73.3" upper_limit="177.1"/>
                    <measurement group_id="O11" value="130.1" lower_limit="70.0" upper_limit="241.9"/>
                    <measurement group_id="O12" value="98.1" lower_limit="55.0" upper_limit="175.1"/>
                    <measurement group_id="O13" value="104.4" lower_limit="58.4" upper_limit="186.5"/>
                    <measurement group_id="O14" value="120.3" lower_limit="72.6" upper_limit="199.3"/>
                    <measurement group_id="O15" value="84.1" lower_limit="44.2" upper_limit="160.3"/>
                    <measurement group_id="O16" value="116.0" lower_limit="54.0" upper_limit="249.4"/>
                    <measurement group_id="O17" value="80.9" lower_limit="42.1" upper_limit="155.4"/>
                    <measurement group_id="O18" value="131.1" lower_limit="57.6" upper_limit="298.6"/>
                    <measurement group_id="O19" value="241.9" lower_limit="140.2" upper_limit="417.5"/>
                    <measurement group_id="O20" value="136.7" lower_limit="75.7" upper_limit="246.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="24"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="26"/>
                    <count group_id="O7" value="24"/>
                    <count group_id="O8" value="27"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="25"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="24"/>
                    <count group_id="O13" value="21"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="19"/>
                    <count group_id="O16" value="8"/>
                    <count group_id="O17" value="14"/>
                    <count group_id="O18" value="10"/>
                    <count group_id="O19" value="10"/>
                    <count group_id="O20" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.1" lower_limit="52.5" upper_limit="194.6"/>
                    <measurement group_id="O2" value="138.3" lower_limit="80.8" upper_limit="236.9"/>
                    <measurement group_id="O3" value="124.4" lower_limit="78.5" upper_limit="197.0"/>
                    <measurement group_id="O4" value="91.2" lower_limit="51.2" upper_limit="162.3"/>
                    <measurement group_id="O5" value="71.3" lower_limit="40.0" upper_limit="126.9"/>
                    <measurement group_id="O6" value="103.2" lower_limit="60.6" upper_limit="175.8"/>
                    <measurement group_id="O7" value="94.3" lower_limit="54.4" upper_limit="163.2"/>
                    <measurement group_id="O8" value="144.9" lower_limit="82.9" upper_limit="253.1"/>
                    <measurement group_id="O9" value="105.1" lower_limit="57.8" upper_limit="191.1"/>
                    <measurement group_id="O10" value="147.2" lower_limit="92.4" upper_limit="234.4"/>
                    <measurement group_id="O11" value="118.0" lower_limit="66.8" upper_limit="208.6"/>
                    <measurement group_id="O12" value="118.3" lower_limit="71.4" upper_limit="195.8"/>
                    <measurement group_id="O13" value="115.7" lower_limit="57.7" upper_limit="232.0"/>
                    <measurement group_id="O14" value="132.0" lower_limit="79.7" upper_limit="218.5"/>
                    <measurement group_id="O15" value="94.2" lower_limit="49.1" upper_limit="180.7"/>
                    <measurement group_id="O16" value="123.4" lower_limit="26.5" upper_limit="574.3"/>
                    <measurement group_id="O17" value="66.8" lower_limit="32.2" upper_limit="138.6"/>
                    <measurement group_id="O18" value="107.4" lower_limit="43.5" upper_limit="265.1"/>
                    <measurement group_id="O19" value="202.2" lower_limit="110.2" upper_limit="370.9"/>
                    <measurement group_id="O20" value="187.3" lower_limit="105.6" upper_limit="332.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)</title>
        <description>GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA). Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5(NOR-107,NOR-210, NOR-204).</description>
        <time_frame>Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study</time_frame>
        <population>PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O2">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O3">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O4">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O5">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible participants who received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O6">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O7">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O8">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O9">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O10">
            <title>NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O11">
            <title>NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O12">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose</title>
            <description>Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O13">
            <title>NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose</title>
            <description>Eligible participants who received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O14">
            <title>NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose</title>
            <description>Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O15">
            <title>NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose</title>
            <description>Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O16">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose</title>
            <description>Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O17">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)</title>
            <description>Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O18">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)</title>
            <description>Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O19">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose</title>
            <description>Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O20">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose</title>
            <description>Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)</title>
          <description>GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA). Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5(NOR-107,NOR-210, NOR-204).</description>
          <population>PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="26"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="27"/>
                <count group_id="O7" value="25"/>
                <count group_id="O8" value="28"/>
                <count group_id="O9" value="22"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="19"/>
                <count group_id="O12" value="25"/>
                <count group_id="O13" value="24"/>
                <count group_id="O14" value="24"/>
                <count group_id="O15" value="24"/>
                <count group_id="O16" value="29"/>
                <count group_id="O17" value="39"/>
                <count group_id="O18" value="14"/>
                <count group_id="O19" value="35"/>
                <count group_id="O20" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1030.5" lower_limit="543.6" upper_limit="1953.7"/>
                    <measurement group_id="O2" value="689.8" lower_limit="295.3" upper_limit="1611.4"/>
                    <measurement group_id="O3" value="646.2" lower_limit="354.3" upper_limit="1178.4"/>
                    <measurement group_id="O4" value="620.9" lower_limit="326.7" upper_limit="1180.1"/>
                    <measurement group_id="O5" value="547.4" lower_limit="334.5" upper_limit="895.6"/>
                    <measurement group_id="O6" value="539.6" lower_limit="293.3" upper_limit="992.5"/>
                    <measurement group_id="O7" value="1089.2" lower_limit="599.9" upper_limit="1977.6"/>
                    <measurement group_id="O8" value="856.1" lower_limit="471.5" upper_limit="1554.3"/>
                    <measurement group_id="O9" value="749.7" lower_limit="406.6" upper_limit="1382.5"/>
                    <measurement group_id="O10" value="770.6" lower_limit="413.5" upper_limit="1436.2"/>
                    <measurement group_id="O11" value="925.3" lower_limit="366.0" upper_limit="2339.3"/>
                    <measurement group_id="O12" value="777.3" lower_limit="413.1" upper_limit="1462.8"/>
                    <measurement group_id="O13" value="908.6" lower_limit="501.0" upper_limit="1647.8"/>
                    <measurement group_id="O14" value="640.4" lower_limit="378.5" upper_limit="1083.5"/>
                    <measurement group_id="O15" value="160.1" lower_limit="78.6" upper_limit="326.1"/>
                    <measurement group_id="O16" value="671.5" lower_limit="432.5" upper_limit="1042.4"/>
                    <measurement group_id="O17" value="769.8" lower_limit="559.5" upper_limit="1059.0"/>
                    <measurement group_id="O18" value="493.1" lower_limit="170.7" upper_limit="1424.8"/>
                    <measurement group_id="O19" value="683.8" lower_limit="460.7" upper_limit="1014.9"/>
                    <measurement group_id="O20" value="851.8" lower_limit="534.3" upper_limit="1357.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="21"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="975.2" lower_limit="508.7" upper_limit="1869.6"/>
                    <measurement group_id="O2" value="649.3" lower_limit="285.2" upper_limit="1478.2"/>
                    <measurement group_id="O3" value="544.9" lower_limit="297.5" upper_limit="998.3"/>
                    <measurement group_id="O4" value="648.7" lower_limit="324.3" upper_limit="1297.5"/>
                    <measurement group_id="O5" value="475.4" lower_limit="284.8" upper_limit="793.4"/>
                    <measurement group_id="O6" value="535.4" lower_limit="287.5" upper_limit="997.1"/>
                    <measurement group_id="O7" value="1086.1" lower_limit="613.7" upper_limit="1922.0"/>
                    <measurement group_id="O8" value="839.1" lower_limit="469.7" upper_limit="1499.0"/>
                    <measurement group_id="O9" value="729.3" lower_limit="380.1" upper_limit="1399.5"/>
                    <measurement group_id="O10" value="731.0" lower_limit="382.7" upper_limit="1396.2"/>
                    <measurement group_id="O11" value="932.8" lower_limit="402.0" upper_limit="2164.8"/>
                    <measurement group_id="O12" value="16822.8" lower_limit="11052.9" upper_limit="25604.9"/>
                    <measurement group_id="O13" value="21215.2" lower_limit="15921.0" upper_limit="28269.9"/>
                    <measurement group_id="O14" value="14102.7" lower_limit="9666.5" upper_limit="20574.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O15" value="10798.6" lower_limit="7482.3" upper_limit="15584.8"/>
                    <measurement group_id="O16" value="630.6" lower_limit="407.9" upper_limit="974.8"/>
                    <measurement group_id="O17" value="734.8" lower_limit="544.2" upper_limit="992.1"/>
                    <measurement group_id="O18" value="694.7" lower_limit="249.8" upper_limit="1931.4"/>
                    <measurement group_id="O19" value="10862.2" lower_limit="8363.3" upper_limit="14107.7"/>
                    <measurement group_id="O20" value="8286.7" lower_limit="6204.3" upper_limit="11068.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="6915.9" lower_limit="4770.3" upper_limit="10026.5"/>
                    <measurement group_id="O17" value="3909.4" lower_limit="2555.3" upper_limit="5981.0"/>
                    <measurement group_id="O18" value="7407.6" lower_limit="3545.0" upper_limit="15479.0"/>
                    <measurement group_id="O19" value="10851.2" lower_limit="8549.3" upper_limit="13772.9"/>
                    <measurement group_id="O20" value="8143.0" lower_limit="6132.6" upper_limit="10812.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15032.5" lower_limit="10033.4" upper_limit="22522.2"/>
                    <measurement group_id="O2" value="12246.2" lower_limit="7488.7" upper_limit="20025.9"/>
                    <measurement group_id="O3" value="16739.1" lower_limit="11460.0" upper_limit="24450.0"/>
                    <measurement group_id="O4" value="13673.2" lower_limit="8411.3" upper_limit="22226.9"/>
                    <measurement group_id="O5" value="12847.2" lower_limit="9036.9" upper_limit="18264.2"/>
                    <measurement group_id="O6" value="18464.0" lower_limit="14207.7" upper_limit="23995.3"/>
                    <measurement group_id="O7" value="15242.3" lower_limit="11298.2" upper_limit="20563.2"/>
                    <measurement group_id="O8" value="15071.0" lower_limit="9104.8" upper_limit="24946.5"/>
                    <measurement group_id="O9" value="25738.6" lower_limit="16696.8" upper_limit="39676.9"/>
                    <measurement group_id="O10" value="14709.3" lower_limit="10110.9" upper_limit="21399.2"/>
                    <measurement group_id="O11" value="12428.4" lower_limit="6942.7" upper_limit="22248.5"/>
                    <measurement group_id="O12" value="14302.9" lower_limit="10081.6" upper_limit="20291.8"/>
                    <measurement group_id="O13" value="18086.8" lower_limit="13594.7" upper_limit="24063.2"/>
                    <measurement group_id="O14" value="11282.4" lower_limit="8142.8" upper_limit="15632.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="10684.3" lower_limit="8532.4" upper_limit="13378.9"/>
                    <measurement group_id="O17" value="5646.8" lower_limit="4043.4" upper_limit="7886.1"/>
                    <measurement group_id="O18" value="7944.8" lower_limit="4570.2" upper_limit="13811.2"/>
                    <measurement group_id="O19" value="9388.2" lower_limit="7285.3" upper_limit="12098.2"/>
                    <measurement group_id="O20" value="7316.3" lower_limit="5685.6" upper_limit="9414.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 208</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6015.9" lower_limit="4271.9" upper_limit="8471.9"/>
                    <measurement group_id="O2" value="4784.5" lower_limit="3114.9" upper_limit="7349.0"/>
                    <measurement group_id="O3" value="6231.0" lower_limit="4321.0" upper_limit="8985.3"/>
                    <measurement group_id="O4" value="5675.5" lower_limit="3783.7" upper_limit="8513.4"/>
                    <measurement group_id="O5" value="4212.3" lower_limit="3065.0" upper_limit="5789.1"/>
                    <measurement group_id="O6" value="4997.4" lower_limit="3748.7" upper_limit="6662.0"/>
                    <measurement group_id="O7" value="5577.8" lower_limit="4072.7" upper_limit="7639.2"/>
                    <measurement group_id="O8" value="6686.7" lower_limit="4766.4" upper_limit="9380.5"/>
                    <measurement group_id="O9" value="7761.2" lower_limit="5226.5" upper_limit="11525.1"/>
                    <measurement group_id="O10" value="5274.3" lower_limit="3746.7" upper_limit="7424.6"/>
                    <measurement group_id="O11" value="4978.7" lower_limit="3275.4" upper_limit="7567.6"/>
                    <measurement group_id="O12" value="7082.7" lower_limit="5051.7" upper_limit="9930.2"/>
                    <measurement group_id="O13" value="7469.9" lower_limit="5874.5" upper_limit="9498.6"/>
                    <measurement group_id="O14" value="5355.9" lower_limit="4082.7" upper_limit="7026.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="5970.0" lower_limit="4586.1" upper_limit="7771.7"/>
                    <measurement group_id="O17" value="4137.3" lower_limit="3176.2" upper_limit="5389.2"/>
                    <measurement group_id="O18" value="3745.8" lower_limit="1975.8" upper_limit="7101.5"/>
                    <measurement group_id="O19" value="5320.5" lower_limit="4169.4" upper_limit="6789.4"/>
                    <measurement group_id="O20" value="5020.4" lower_limit="3878.5" upper_limit="6498.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="26"/>
                    <count group_id="O17" value="37"/>
                    <count group_id="O18" value="10"/>
                    <count group_id="O19" value="32"/>
                    <count group_id="O20" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O15" value="1662.0" lower_limit="1203.1" upper_limit="2296.0"/>
                    <measurement group_id="O16" value="1804.4" lower_limit="1405.6" upper_limit="2316.4"/>
                    <measurement group_id="O17" value="1477.4" lower_limit="1016.3" upper_limit="2147.7"/>
                    <measurement group_id="O18" value="1672.4" lower_limit="656.0" upper_limit="4263.7"/>
                    <measurement group_id="O19" value="1770.6" lower_limit="1310.4" upper_limit="2392.3"/>
                    <measurement group_id="O20" value="1635.0" lower_limit="1194.2" upper_limit="2238.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="27"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="21"/>
                    <count group_id="O16" value="24"/>
                    <count group_id="O17" value="35"/>
                    <count group_id="O18" value="13"/>
                    <count group_id="O19" value="29"/>
                    <count group_id="O20" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2229.0" lower_limit="1481.3" upper_limit="3354.1"/>
                    <measurement group_id="O2" value="1493.3" lower_limit="987.8" upper_limit="2257.6"/>
                    <measurement group_id="O3" value="2058.7" lower_limit="1538.0" upper_limit="2755.7"/>
                    <measurement group_id="O4" value="2227.0" lower_limit="1581.4" upper_limit="3136.2"/>
                    <measurement group_id="O5" value="1465.7" lower_limit="1056.7" upper_limit="2032.8"/>
                    <measurement group_id="O6" value="1568.0" lower_limit="1188.6" upper_limit="2068.5"/>
                    <measurement group_id="O7" value="2156.1" lower_limit="1527.7" upper_limit="3042.9"/>
                    <measurement group_id="O8" value="1913.2" lower_limit="1386.8" upper_limit="2639.4"/>
                    <measurement group_id="O9" value="2063.1" lower_limit="1370.8" upper_limit="3105.0"/>
                    <measurement group_id="O10" value="1702.4" lower_limit="1165.5" upper_limit="2486.6"/>
                    <measurement group_id="O11" value="1579.5" lower_limit="977.5" upper_limit="2552.2"/>
                    <measurement group_id="O12" value="2422.7" lower_limit="1732.0" upper_limit="3388.9"/>
                    <measurement group_id="O13" value="2914.8" lower_limit="2270.4" upper_limit="3742.1"/>
                    <measurement group_id="O14" value="2077.8" lower_limit="1523.3" upper_limit="2834.1"/>
                    <measurement group_id="O15" value="1500.9" lower_limit="1031.3" upper_limit="2184.2"/>
                    <measurement group_id="O16" value="2006.4" lower_limit="1373.3" upper_limit="2931.3"/>
                    <measurement group_id="O17" value="1932.8" lower_limit="1245.7" upper_limit="2998.7"/>
                    <measurement group_id="O18" value="1254.9" lower_limit="701.7" upper_limit="2244.2"/>
                    <measurement group_id="O19" value="1670.1" lower_limit="1258.5" upper_limit="2216.4"/>
                    <measurement group_id="O20" value="1700.5" lower_limit="1224.7" upper_limit="2361.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="26"/>
                    <count group_id="O7" value="23"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="23"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="20"/>
                    <count group_id="O16" value="18"/>
                    <count group_id="O17" value="22"/>
                    <count group_id="O18" value="11"/>
                    <count group_id="O19" value="20"/>
                    <count group_id="O20" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2095.5" lower_limit="1272.0" upper_limit="3452.2"/>
                    <measurement group_id="O2" value="1727.7" lower_limit="1016.1" upper_limit="2937.8"/>
                    <measurement group_id="O3" value="2541.1" lower_limit="1618.3" upper_limit="3990.1"/>
                    <measurement group_id="O4" value="1958.2" lower_limit="1363.0" upper_limit="2813.3"/>
                    <measurement group_id="O5" value="1802.9" lower_limit="1185.9" upper_limit="2740.8"/>
                    <measurement group_id="O6" value="1565.5" lower_limit="1181.0" upper_limit="2075.1"/>
                    <measurement group_id="O7" value="2934.1" lower_limit="1993.0" upper_limit="4319.7"/>
                    <measurement group_id="O8" value="2107.0" lower_limit="1384.3" upper_limit="3207.0"/>
                    <measurement group_id="O9" value="1965.0" lower_limit="1287.9" upper_limit="2997.9"/>
                    <measurement group_id="O10" value="1679.0" lower_limit="1208.0" upper_limit="2333.5"/>
                    <measurement group_id="O11" value="2025.2" lower_limit="1254.9" upper_limit="3268.3"/>
                    <measurement group_id="O12" value="2335.8" lower_limit="1724.4" upper_limit="3163.8"/>
                    <measurement group_id="O13" value="2635.7" lower_limit="1936.2" upper_limit="3587.9"/>
                    <measurement group_id="O14" value="2016.6" lower_limit="1500.0" upper_limit="2711.1"/>
                    <measurement group_id="O15" value="1627.4" lower_limit="1127.0" upper_limit="2350.1"/>
                    <measurement group_id="O16" value="1512.1" lower_limit="1032.5" upper_limit="2214.6"/>
                    <measurement group_id="O17" value="1441.7" lower_limit="926.9" upper_limit="2242.4"/>
                    <measurement group_id="O18" value="1238.3" lower_limit="841.5" upper_limit="1822.1"/>
                    <measurement group_id="O19" value="1585.6" lower_limit="1101.6" upper_limit="2282.3"/>
                    <measurement group_id="O20" value="1392.4" lower_limit="917.6" upper_limit="2112.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="24"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="26"/>
                    <count group_id="O7" value="24"/>
                    <count group_id="O8" value="27"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="25"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="24"/>
                    <count group_id="O13" value="21"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="19"/>
                    <count group_id="O16" value="8"/>
                    <count group_id="O17" value="15"/>
                    <count group_id="O18" value="10"/>
                    <count group_id="O19" value="10"/>
                    <count group_id="O20" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1732.3" lower_limit="1133.8" upper_limit="2646.8"/>
                    <measurement group_id="O2" value="1563.6" lower_limit="957.9" upper_limit="2552.6"/>
                    <measurement group_id="O3" value="2345.8" lower_limit="1566.6" upper_limit="3512.7"/>
                    <measurement group_id="O4" value="2009.8" lower_limit="1396.6" upper_limit="2892.2"/>
                    <measurement group_id="O5" value="1664.8" lower_limit="1100.7" upper_limit="2518.1"/>
                    <measurement group_id="O6" value="1781.2" lower_limit="1102.5" upper_limit="2877.7"/>
                    <measurement group_id="O7" value="2116.5" lower_limit="1597.7" upper_limit="2803.7"/>
                    <measurement group_id="O8" value="2270.3" lower_limit="1536.1" upper_limit="3355.5"/>
                    <measurement group_id="O9" value="2181.9" lower_limit="1360.4" upper_limit="3499.2"/>
                    <measurement group_id="O10" value="1811.9" lower_limit="1173.5" upper_limit="2797.8"/>
                    <measurement group_id="O11" value="1434.9" lower_limit="956.9" upper_limit="2151.6"/>
                    <measurement group_id="O12" value="2036.9" lower_limit="1475.0" upper_limit="2812.9"/>
                    <measurement group_id="O13" value="2405.4" lower_limit="1763.1" upper_limit="3281.8"/>
                    <measurement group_id="O14" value="1817.7" lower_limit="1256.1" upper_limit="2630.5"/>
                    <measurement group_id="O15" value="1803.8" lower_limit="1205.4" upper_limit="2699.1"/>
                    <measurement group_id="O16" value="1937.4" lower_limit="1141.5" upper_limit="3288.2"/>
                    <measurement group_id="O17" value="1255.5" lower_limit="709.1" upper_limit="2223.1"/>
                    <measurement group_id="O18" value="1048.6" lower_limit="566.7" upper_limit="1940.4"/>
                    <measurement group_id="O19" value="2060.5" lower_limit="1422.7" upper_limit="2984.3"/>
                    <measurement group_id="O20" value="1687.2" lower_limit="1031.7" upper_limit="2759.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA</title>
        <description>GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. Data reported for up to Year 5 was collected at Baseline (NOR-107,NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107,NOR-210, NOR-204).</description>
        <time_frame>Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study</time_frame>
        <population>PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O2">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
          </group>
          <group group_id="O3">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O4">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O5">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible participants who received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O6">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O7">
            <title>NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O8">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O9">
            <title>NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O10">
            <title>NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O11">
            <title>NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose</title>
            <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O12">
            <title>NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose</title>
            <description>Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O13">
            <title>NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose</title>
            <description>Eligible participants who received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O14">
            <title>NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose</title>
            <description>Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O15">
            <title>NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose</title>
            <description>Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O16">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose</title>
            <description>Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O17">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)</title>
            <description>Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O18">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)</title>
            <description>Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O19">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose</title>
            <description>Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
          <group group_id="O20">
            <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose</title>
            <description>Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA</title>
          <description>GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. Data reported for up to Year 5 was collected at Baseline (NOR-107,NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107,NOR-210, NOR-204).</description>
          <population>PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="26"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="27"/>
                <count group_id="O7" value="25"/>
                <count group_id="O8" value="28"/>
                <count group_id="O9" value="22"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="19"/>
                <count group_id="O12" value="25"/>
                <count group_id="O13" value="24"/>
                <count group_id="O14" value="24"/>
                <count group_id="O15" value="24"/>
                <count group_id="O16" value="29"/>
                <count group_id="O17" value="39"/>
                <count group_id="O18" value="14"/>
                <count group_id="O19" value="35"/>
                <count group_id="O20" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1209.8" lower_limit="617.2" upper_limit="2371.5"/>
                    <measurement group_id="O2" value="1248.3" lower_limit="665.1" upper_limit="2343.0"/>
                    <measurement group_id="O3" value="1423.3" lower_limit="799.5" upper_limit="2533.7"/>
                    <measurement group_id="O4" value="954.0" lower_limit="530.1" upper_limit="1716.8"/>
                    <measurement group_id="O5" value="838.8" lower_limit="507.6" upper_limit="1386.1"/>
                    <measurement group_id="O6" value="1239.7" lower_limit="705.8" upper_limit="2177.4"/>
                    <measurement group_id="O7" value="1373.7" lower_limit="792.4" upper_limit="2381.6"/>
                    <measurement group_id="O8" value="1179.5" lower_limit="677.5" upper_limit="2053.4"/>
                    <measurement group_id="O9" value="1133.9" lower_limit="648.4" upper_limit="1982.8"/>
                    <measurement group_id="O10" value="1442.1" lower_limit="864.3" upper_limit="2406.1"/>
                    <measurement group_id="O11" value="2069.2" lower_limit="1362.0" upper_limit="3143.7"/>
                    <measurement group_id="O12" value="1078.9" lower_limit="678.4" upper_limit="1715.6"/>
                    <measurement group_id="O13" value="1308.9" lower_limit="779.3" upper_limit="2198.4"/>
                    <measurement group_id="O14" value="1598.5" lower_limit="952.6" upper_limit="2682.3"/>
                    <measurement group_id="O15" value="93.1" lower_limit="58.8" upper_limit="147.3"/>
                    <measurement group_id="O16" value="1213.2" lower_limit="658.2" upper_limit="2236.1"/>
                    <measurement group_id="O17" value="826.1" lower_limit="508.7" upper_limit="1341.7"/>
                    <measurement group_id="O18" value="1288.0" lower_limit="570.8" upper_limit="2906.4"/>
                    <measurement group_id="O19" value="1263.5" lower_limit="794.7" upper_limit="2009.0"/>
                    <measurement group_id="O20" value="1149.0" lower_limit="672.9" upper_limit="1961.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="21"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1218.3" lower_limit="609.8" upper_limit="2433.7"/>
                    <measurement group_id="O2" value="1233.2" lower_limit="658.4" upper_limit="2309.7"/>
                    <measurement group_id="O3" value="1471.1" lower_limit="841.2" upper_limit="2572.7"/>
                    <measurement group_id="O4" value="953.8" lower_limit="549.5" upper_limit="1655.4"/>
                    <measurement group_id="O5" value="754.4" lower_limit="464.2" upper_limit="1226.0"/>
                    <measurement group_id="O6" value="1198.8" lower_limit="688.3" upper_limit="2088.0"/>
                    <measurement group_id="O7" value="1310.7" lower_limit="797.3" upper_limit="2154.5"/>
                    <measurement group_id="O8" value="1246.3" lower_limit="710.3" upper_limit="2187.0"/>
                    <measurement group_id="O9" value="1086.0" lower_limit="619.5" upper_limit="1903.7"/>
                    <measurement group_id="O10" value="1491.7" lower_limit="983.7" upper_limit="2262.0"/>
                    <measurement group_id="O11" value="1940.6" lower_limit="1259.0" upper_limit="2991.2"/>
                    <measurement group_id="O12" value="8866.0" lower_limit="6415.5" upper_limit="12252.6"/>
                    <measurement group_id="O13" value="13710.2" lower_limit="10111.0" upper_limit="18590.5"/>
                    <measurement group_id="O14" value="10202.3" lower_limit="6715.1" upper_limit="15500.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O15" value="10170.0" lower_limit="7301.6" upper_limit="14165.2"/>
                    <measurement group_id="O16" value="1172.6" lower_limit="630.4" upper_limit="2181.1"/>
                    <measurement group_id="O17" value="818.6" lower_limit="510.4" upper_limit="1313.0"/>
                    <measurement group_id="O18" value="1251.3" lower_limit="563.1" upper_limit="2780.5"/>
                    <measurement group_id="O19" value="9284.7" lower_limit="6772.0" upper_limit="12729.9"/>
                    <measurement group_id="O20" value="8508.2" lower_limit="5798.6" upper_limit="12484.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="5938.0" lower_limit="3771.8" upper_limit="9348.2"/>
                    <measurement group_id="O17" value="4248.1" lower_limit="2787.2" upper_limit="6474.8"/>
                    <measurement group_id="O18" value="8348.3" lower_limit="5370.9" upper_limit="12976.3"/>
                    <measurement group_id="O19" value="9415.5" lower_limit="7120.6" upper_limit="12450.1"/>
                    <measurement group_id="O20" value="8518.7" lower_limit="5970.1" upper_limit="12155.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5051.3" lower_limit="3144.0" upper_limit="8115.7"/>
                    <measurement group_id="O2" value="8644.5" lower_limit="6368.1" upper_limit="11734.7"/>
                    <measurement group_id="O3" value="5651.7" lower_limit="4159.3" upper_limit="7679.4"/>
                    <measurement group_id="O4" value="3909.2" lower_limit="2620.5" upper_limit="5831.7"/>
                    <measurement group_id="O5" value="6655.7" lower_limit="4670.1" upper_limit="9485.5"/>
                    <measurement group_id="O6" value="7585.7" lower_limit="5687.6" upper_limit="10117.3"/>
                    <measurement group_id="O7" value="3296.3" lower_limit="2075.7" upper_limit="5234.7"/>
                    <measurement group_id="O8" value="9110.9" lower_limit="5865.5" upper_limit="14152.2"/>
                    <measurement group_id="O9" value="4762.7" lower_limit="2918.8" upper_limit="7771.4"/>
                    <measurement group_id="O10" value="10733.0" lower_limit="7902.0" upper_limit="14578.1"/>
                    <measurement group_id="O11" value="9544.8" lower_limit="6846.7" upper_limit="13306.1"/>
                    <measurement group_id="O12" value="7083.6" lower_limit="5125.3" upper_limit="9790.1"/>
                    <measurement group_id="O13" value="10333.3" lower_limit="7485.5" upper_limit="14264.4"/>
                    <measurement group_id="O14" value="7801.7" lower_limit="5379.1" upper_limit="11315.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="9761.9" lower_limit="6487.9" upper_limit="14688.1"/>
                    <measurement group_id="O17" value="5961.1" lower_limit="4365.7" upper_limit="8139.7"/>
                    <measurement group_id="O18" value="8689.8" lower_limit="6309.5" upper_limit="11968.1"/>
                    <measurement group_id="O19" value="7673.7" lower_limit="5733.9" upper_limit="10269.7"/>
                    <measurement group_id="O20" value="7610.5" lower_limit="5336.3" upper_limit="10854.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 208</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                    <count group_id="O17" value="0"/>
                    <count group_id="O18" value="0"/>
                    <count group_id="O19" value="0"/>
                    <count group_id="O20" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2805.0" lower_limit="1665.3" upper_limit="4724.8"/>
                    <measurement group_id="O2" value="3797.7" lower_limit="2654.3" upper_limit="5433.8"/>
                    <measurement group_id="O3" value="2757.9" lower_limit="1631.0" upper_limit="4663.4"/>
                    <measurement group_id="O4" value="2575.3" lower_limit="1695.6" upper_limit="3911.3"/>
                    <measurement group_id="O5" value="2861.7" lower_limit="2000.7" upper_limit="4093.2"/>
                    <measurement group_id="O6" value="3086.6" lower_limit="2194.7" upper_limit="4341.0"/>
                    <measurement group_id="O7" value="2239.3" lower_limit="1451.7" upper_limit="3454.4"/>
                    <measurement group_id="O8" value="4668.9" lower_limit="3069.6" upper_limit="7101.4"/>
                    <measurement group_id="O9" value="2349.9" lower_limit="1405.2" upper_limit="3929.8"/>
                    <measurement group_id="O10" value="4661.9" lower_limit="3401.9" upper_limit="6388.5"/>
                    <measurement group_id="O11" value="4450.1" lower_limit="2994.6" upper_limit="6613.0"/>
                    <measurement group_id="O12" value="4004.2" lower_limit="2834.4" upper_limit="5656.7"/>
                    <measurement group_id="O13" value="4807.4" lower_limit="3225.4" upper_limit="7165.3"/>
                    <measurement group_id="O14" value="4177.3" lower_limit="2914.0" upper_limit="5988.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="29"/>
                    <count group_id="O17" value="39"/>
                    <count group_id="O18" value="14"/>
                    <count group_id="O19" value="35"/>
                    <count group_id="O20" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O16" value="5710.0" lower_limit="3654.0" upper_limit="8922.7"/>
                    <measurement group_id="O17" value="3949.0" lower_limit="2991.2" upper_limit="5213.6"/>
                    <measurement group_id="O18" value="4825.8" lower_limit="3063.2" upper_limit="7602.6"/>
                    <measurement group_id="O19" value="5389.0" lower_limit="4070.1" upper_limit="7135.2"/>
                    <measurement group_id="O20" value="5415.4" lower_limit="3633.4" upper_limit="8071.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="24"/>
                    <count group_id="O16" value="26"/>
                    <count group_id="O17" value="37"/>
                    <count group_id="O18" value="10"/>
                    <count group_id="O19" value="32"/>
                    <count group_id="O20" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O15" value="1513.3" lower_limit="897.0" upper_limit="2553.2"/>
                    <measurement group_id="O16" value="2344.8" lower_limit="1508.6" upper_limit="3644.5"/>
                    <measurement group_id="O17" value="1465.5" lower_limit="1039.9" upper_limit="2065.3"/>
                    <measurement group_id="O18" value="4160.4" lower_limit="1968.6" upper_limit="8792.4"/>
                    <measurement group_id="O19" value="2244.0" lower_limit="1462.9" upper_limit="3442.1"/>
                    <measurement group_id="O20" value="2380.4" lower_limit="1507.4" upper_limit="3759.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="27"/>
                    <count group_id="O7" value="25"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="27"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="24"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="21"/>
                    <count group_id="O16" value="24"/>
                    <count group_id="O17" value="35"/>
                    <count group_id="O18" value="13"/>
                    <count group_id="O19" value="29"/>
                    <count group_id="O20" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1643.9" lower_limit="850.8" upper_limit="3176.6"/>
                    <measurement group_id="O2" value="1874.7" lower_limit="1066.5" upper_limit="3295.6"/>
                    <measurement group_id="O3" value="1756.7" lower_limit="1193.6" upper_limit="2585.3"/>
                    <measurement group_id="O4" value="1159.4" lower_limit="731.0" upper_limit="1838.7"/>
                    <measurement group_id="O5" value="1193.5" lower_limit="780.4" upper_limit="1825.4"/>
                    <measurement group_id="O6" value="1385.2" lower_limit="946.0" upper_limit="2028.2"/>
                    <measurement group_id="O7" value="1425.3" lower_limit="844.2" upper_limit="2406.6"/>
                    <measurement group_id="O8" value="1705.3" lower_limit="1024.2" upper_limit="2839.3"/>
                    <measurement group_id="O9" value="1166.5" lower_limit="608.1" upper_limit="2237.6"/>
                    <measurement group_id="O10" value="1775.4" lower_limit="1208.6" upper_limit="2608.1"/>
                    <measurement group_id="O11" value="1783.7" lower_limit="1093.8" upper_limit="2909.0"/>
                    <measurement group_id="O12" value="1880.8" lower_limit="1254.3" upper_limit="2820.4"/>
                    <measurement group_id="O13" value="2079.5" lower_limit="1465.2" upper_limit="2951.4"/>
                    <measurement group_id="O14" value="1946.0" lower_limit="1303.7" upper_limit="2904.8"/>
                    <measurement group_id="O15" value="1202.9" lower_limit="682.0" upper_limit="2121.6"/>
                    <measurement group_id="O16" value="2200.3" lower_limit="1284.6" upper_limit="3768.8"/>
                    <measurement group_id="O17" value="1771.1" lower_limit="1276.4" upper_limit="2457.6"/>
                    <measurement group_id="O18" value="2155.0" lower_limit="1293.4" upper_limit="3590.8"/>
                    <measurement group_id="O19" value="2297.5" lower_limit="1422.8" upper_limit="3709.9"/>
                    <measurement group_id="O20" value="2304.2" lower_limit="1369.0" upper_limit="3878.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="26"/>
                    <count group_id="O7" value="23"/>
                    <count group_id="O8" value="28"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="25"/>
                    <count group_id="O13" value="23"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="20"/>
                    <count group_id="O16" value="18"/>
                    <count group_id="O17" value="22"/>
                    <count group_id="O18" value="11"/>
                    <count group_id="O19" value="20"/>
                    <count group_id="O20" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1580.2" lower_limit="856.2" upper_limit="2916.6"/>
                    <measurement group_id="O2" value="2128.6" lower_limit="1214.1" upper_limit="3732.0"/>
                    <measurement group_id="O3" value="1828.6" lower_limit="1183.6" upper_limit="2825.2"/>
                    <measurement group_id="O4" value="1234.2" lower_limit="791.8" upper_limit="1923.6"/>
                    <measurement group_id="O5" value="1283.8" lower_limit="870.2" upper_limit="1894.0"/>
                    <measurement group_id="O6" value="1714.5" lower_limit="1133.1" upper_limit="2594.2"/>
                    <measurement group_id="O7" value="2114.3" lower_limit="1369.8" upper_limit="3263.4"/>
                    <measurement group_id="O8" value="1858.2" lower_limit="1107.6" upper_limit="3117.5"/>
                    <measurement group_id="O9" value="1115.2" lower_limit="597.5" upper_limit="2081.7"/>
                    <measurement group_id="O10" value="1762.5" lower_limit="1170.1" upper_limit="2655.0"/>
                    <measurement group_id="O11" value="2173.9" lower_limit="1287.5" upper_limit="3670.6"/>
                    <measurement group_id="O12" value="1702.1" lower_limit="976.9" upper_limit="2965.5"/>
                    <measurement group_id="O13" value="2766.1" lower_limit="1630.1" upper_limit="4694.0"/>
                    <measurement group_id="O14" value="2044.1" lower_limit="1416.3" upper_limit="2950.2"/>
                    <measurement group_id="O15" value="1254.0" lower_limit="743.5" upper_limit="2115.0"/>
                    <measurement group_id="O16" value="1514.3" lower_limit="895.9" upper_limit="2559.5"/>
                    <measurement group_id="O17" value="1267.2" lower_limit="788.9" upper_limit="2035.5"/>
                    <measurement group_id="O18" value="1806.5" lower_limit="1032.7" upper_limit="3160.1"/>
                    <measurement group_id="O19" value="2466.9" lower_limit="1489.0" upper_limit="4086.9"/>
                    <measurement group_id="O20" value="1823.5" lower_limit="1089.5" upper_limit="3052.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="24"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="26"/>
                    <count group_id="O7" value="24"/>
                    <count group_id="O8" value="27"/>
                    <count group_id="O9" value="22"/>
                    <count group_id="O10" value="25"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="24"/>
                    <count group_id="O13" value="21"/>
                    <count group_id="O14" value="24"/>
                    <count group_id="O15" value="19"/>
                    <count group_id="O16" value="8"/>
                    <count group_id="O17" value="15"/>
                    <count group_id="O18" value="10"/>
                    <count group_id="O19" value="10"/>
                    <count group_id="O20" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1159.9" lower_limit="587.5" upper_limit="2289.8"/>
                    <measurement group_id="O2" value="2232.6" lower_limit="1270.8" upper_limit="3922.1"/>
                    <measurement group_id="O3" value="1702.6" lower_limit="1091.4" upper_limit="2656.0"/>
                    <measurement group_id="O4" value="1135.0" lower_limit="709.5" upper_limit="1815.7"/>
                    <measurement group_id="O5" value="1177.1" lower_limit="774.7" upper_limit="1788.5"/>
                    <measurement group_id="O6" value="1545.6" lower_limit="952.6" upper_limit="2507.9"/>
                    <measurement group_id="O7" value="1410.6" lower_limit="927.5" upper_limit="2145.5"/>
                    <measurement group_id="O8" value="2047.9" lower_limit="1097.6" upper_limit="3821.1"/>
                    <measurement group_id="O9" value="1265.5" lower_limit="682.2" upper_limit="2347.3"/>
                    <measurement group_id="O10" value="2037.4" lower_limit="1364.0" upper_limit="3043.1"/>
                    <measurement group_id="O11" value="1648.1" lower_limit="989.0" upper_limit="2746.2"/>
                    <measurement group_id="O12" value="1746.6" lower_limit="1149.0" upper_limit="2655.0"/>
                    <measurement group_id="O13" value="2225.0" lower_limit="1305.9" upper_limit="3791.0"/>
                    <measurement group_id="O14" value="1624.0" lower_limit="1073.2" upper_limit="2457.7"/>
                    <measurement group_id="O15" value="1241.5" lower_limit="726.4" upper_limit="2121.8"/>
                    <measurement group_id="O16" value="1076.0" lower_limit="406.2" upper_limit="2850.3"/>
                    <measurement group_id="O17" value="912.7" lower_limit="529.7" upper_limit="1572.6"/>
                    <measurement group_id="O18" value="1187.7" lower_limit="680.8" upper_limit="2071.8"/>
                    <measurement group_id="O19" value="1522.7" lower_limit="936.1" upper_limit="2476.8"/>
                    <measurement group_id="O20" value="2097.3" lower_limit="1285.7" upper_limit="3421.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204)</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E2">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose</title>
          <description>Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
        </group>
        <group group_id="E3">
          <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E4">
          <title>NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E5">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose</title>
          <description>Eligible participants who received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.</description>
        </group>
        <group group_id="E6">
          <title>NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E7">
          <title>NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E8">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E9">
          <title>NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E10">
          <title>NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E11">
          <title>NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose</title>
          <description>Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E12">
          <title>NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose</title>
          <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E13">
          <title>NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose</title>
          <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E14">
          <title>NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose</title>
          <description>Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E15">
          <title>NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose</title>
          <description>Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E16">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose</title>
          <description>Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E17">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)</title>
          <description>Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E18">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)</title>
          <description>Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E19">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose</title>
          <description>Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
        <group group_id="E20">
          <title>NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose</title>
          <description>Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Amaurosis fugax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Episcleritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Adult failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Metastatic renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of the tongue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurodegenerative disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="42"/>
              </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>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Takeda (Note: This product was divested to HilleVax in 2022)</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.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/NCT03039790
org study id: NOR-213
secondary id: 2016-004288-37
secondary id: U1111-1189-7907
nct id: NCT03039790
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate descriptively the long-term immunogenicity of at
      least 1 NoV vaccine administration.
Results prepared and posted by Takeda on behalf of Hillevax, the IND holder.

      The drug being tested in this study is called NoV vaccine. NoV vaccine is being tested for
      protection against acute gastroenteritis (AGE) due to norovirus.

      The study will enroll maximum of approximately 575 participants. Participants who previously
      received NoV vaccine in studies NOR-107, NOR-210 and NOR-204 will be enrolled. Participants
      from study NOR-107 will enter the study at the time of their 3rd year post-primary
      vaccination, and from studies NOR-210 and NOR-204, at their 2nd year post-primary
      vaccination. The duration of participation in the study will be different for each
      participant.

      This multi-center trial will be conducted in Belgium and the United States. The overall time
      to participate in this study is maximum 5 years after primary NoV vaccination. Participants
      will have a maximum of 4 visits over 3 years
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay
time frame: Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study
description: GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204) , at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107, NOR-210, NOR-204)
measure: Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay
time frame: Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study
description: GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3 4 and 5 (NOR-107,NOR-210, NOR-204) .
measure: Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)
time frame: Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study
description: GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA). Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5(NOR-107,NOR-210, NOR-204).
measure: Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA
time frame: Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study
description: GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. Data reported for up to Year 5 was collected at Baseline (NOR-107,NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107,NOR-210, NOR-204).
arm group label: NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose
arm group type: Experimental
description: Eligible participants who received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminium hydroxide, IM on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
arm group label: NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose
arm group type: Experimental
description: Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
arm group label: NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose
arm group type: Experimental
description: Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
arm group label: NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose
arm group type: Experimental
description: Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
arm group label: NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 yrs)
arm group type: Experimental
description: Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
arm group label: NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 yrs)
arm group type: Experimental
description: Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
arm group label: NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose
arm group type: Experimental
description: Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
arm group label: NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
arm group type: Experimental
description: Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
intervention type: Biological
intervention name: NoV Vaccine
description: NoV vaccine injection administered.
arm group label: NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose
arm group label: NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose
arm group label: NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose
arm group label: NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose
arm group label: NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose
arm group label: NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose
arm group label: NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose
arm group label: NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose
arm group label: NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose
arm group label: NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose
arm group label: NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose
arm group label: NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose
arm group label: NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose
arm group label: NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose
arm group label: NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose
arm group label: NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose
arm group label: NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 yrs)
arm group label: NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 yrs)
arm group label: NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
arm group label: NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Takeda
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 