xml: <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/NCT06007781</url>
    </required_header>
    <id_info>
      <org_study_id>NOR-109</org_study_id>
      <nct_id>NCT06007781</nct_id>
    </id_info>
    <brief_title>Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants</brief_title>
    <official_title>A Phase 1, Randomized, Double-blind, Multi-center, Placebo-controlled Trial to Evaluate the Safety and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent VLP Vaccine in Healthy Japanese Infants 5 Months of Age at First Trial Vaccine Administration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>HilleVax</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>HilleVax</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a phase 1, randomized, double-blind multi-center, placebo-controlled trial in Japan&#xD;
        to evaluate the safety and immunogenicity of HIL-214 in healthy infants 5 months of age&#xD;
        (-14/+14 days) at first trial vaccine administration. In this protocol, because the trial is&#xD;
        blinded, trial vaccine refers to both the investigational vaccine (HIL-214) and placebo.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The rationale for trial NOR-109 is to evaluate the safety and immunogenicity of HIL-214 in&#xD;
        Japanese pediatric subjects and establish whether the data obtained is consistent with that&#xD;
        previously obtained for non-Japanese pediatric subjects.&#xD;
  &#xD;
        The clinical trials for HIL-214 have so far been performed in Europe, the United States and&#xD;
        several countries in Latin America [26]. The incidence rate of norovirus-attributable disease&#xD;
        in Japan is at least as high as in other developed countries with the highest rates occurring&#xD;
        in children below the age of 5 years and hospitalization most common in very young and very&#xD;
        old populations. The inclusion of infants (5 months [±14 days] of age at the time of first&#xD;
        trial vaccine administration) serves to compare the data obtained for infants of non-Japanese&#xD;
        descent with Japanese infants, in alignment with the global clinical program, and to support&#xD;
        the inclusion of Japanese infants into phase 3. Enrollment and vaccination of the infants&#xD;
        will be performed either before or after the required routine childhood vaccines per the&#xD;
        national immunization schedule.&#xD;
  &#xD;
        This phase 1 trial in Japan aims to assess the safety and immunogenicity of two doses of&#xD;
        HIL-214 administered 4 to 8 weeks apart, in 21 healthy infants aged 5 months at the time of&#xD;
        the first trial vaccine dose administration. A placebo arm is included to allow an unbiased&#xD;
        assessment of safety and immunogenicity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">June 24, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 23, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Subjects will be allocated (2 to1) into one of two trial arms, Arm 1 - One dose of HIL-214; Arm 2 - One dose of placebo.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Objective</measure>
      <time_frame>3 months</time_frame>
      <description>All of the subjects in this trial will be assessed for safety of HIL-214 by comparing the occurrence and intensity of solicited and unsolicited local and systemic reactions to the study vaccine compared with placebo vaccination and including AEs leading to withdrawal of trial vaccine.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of subjects with solicited local AEs</measure>
      <time_frame>up to 7 days post-dose 1 and dose 2.</time_frame>
      <description>Subjects that present with solicited systemic AEs.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of subjects with solicited Systemic AEs</measure>
      <time_frame>up to 7 days post-dose 1 and dose 2.</time_frame>
      <description>Subjects that present with solicited systemic AEs.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of subjects with unsolicited symptomatic AEs</measure>
      <time_frame>up to 28 days post-dose 1 and dose 2.</time_frame>
      <description>Subjects that present with unsolicited symptoms (AEs)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of subjects with AEs leading to withdrawal</measure>
      <time_frame>Up to 56 days post-dose 1</time_frame>
      <description>The number of AEs that lead to vaccine dose withdrawal.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of subjects with Adverse Events and Serious Adverse Events</measure>
      <time_frame>Through study completion, an average of 1 year.</time_frame>
      <description>The number of AEs and SAEs that lead to the subject's withdrawal from the trial</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">21</enrollment>
    <condition>Gastroenteritis</condition>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>2 injections - given on Day 1 and the second given between Day 29 - Day 57</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>HIL-214</intervention_name>
      <description>2 injections - given on Day 1 and the second given between Day 29 - Day 57</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
            -  Male or female subject aged 5 months [-14/+14 days].&#xD;
  &#xD;
            -  Infants who are in good health at the time of entry into the trial as determined by&#xD;
               medical history, physical examination (including vital signs) and clinical judgment of&#xD;
               the investigator.&#xD;
  &#xD;
            -  The subject's legally acceptable representative (LAR) signs and dates a written,&#xD;
               informed consent form (ICF) and any required privacy authorization prior to the&#xD;
               initiation of any trial procedures, after the nature of the trial has been explained&#xD;
               according to local regulatory requirements.&#xD;
  &#xD;
            -  The subject's LAR is willing and able to comply with trial procedures and is available&#xD;
               for the duration of follow-up.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  Clinically significant abnormality in growth by length/height, weight, or head&#xD;
               circumference (according to national guidelines).&#xD;
  &#xD;
            -  Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any&#xD;
               uncorrected congenital malformation of the gastrointestinal tract according to medical&#xD;
               history and/or physical examination.&#xD;
  &#xD;
            -  Chronic use of oral corticosteroids (equivalent to 20 mg/day prednisolone for ≥12&#xD;
               weeks / ≥2 mg/kg body weight /day for ≥2 weeks) within 60 days prior to Visit 1 (use&#xD;
               of inhaled, intranasal, or topical corticosteroids are allowed).&#xD;
  &#xD;
            -  Use of parenteral corticosteroids (equivalent to 20 mg/day prednisolone for ≥12 weeks&#xD;
               / ≥2 mg/kg body weight /day for ≥2 weeks. Use of inhaled, intranasal, or topical&#xD;
               corticosteroid is allowed) within 60 days prior to Visit 1.&#xD;
  &#xD;
            -  Receipt of immunostimulants within 60 days prior to Visit 1.&#xD;
  &#xD;
            -  Receipt of parenteral, epidural, or intra-articular immunoglobulin (Ig) preparations,&#xD;
               blood products, and/or plasma derivatives within 90 days prior to Visit 1 or planned&#xD;
               during the full duration of the trial.&#xD;
  &#xD;
            -  Receipt of immunosuppressive therapy prior to Visit 1.&#xD;
  &#xD;
            -  Known hypersensitivity or allergy to any of the trial vaccine components (including&#xD;
               excipients).&#xD;
  &#xD;
            -  Any clinically significant active infection (as assessed by the investigator) or&#xD;
               temperature ≥38.0°C (&gt;100.4°F), regardless of method used, within 3 days prior to&#xD;
               intended trial vaccine administration.&#xD;
  &#xD;
            -  Gastroenteritis within 7 days before planned dosing (can warrant delay of trial&#xD;
               vaccine administration).&#xD;
  &#xD;
            -  History of, e.g., convulsions/febrile convulsions, or any illness, that, in the&#xD;
               opinion of the investigator, might interfere with the results of the trial or pose&#xD;
               additional risk to the subjects due to participation the trial.&#xD;
  &#xD;
            -  Abnormalities of splenic or thymic function.&#xD;
  &#xD;
            -  Known or suspected impairment/alteration of immune function.&#xD;
  &#xD;
            -  Known bleeding diathesis, or any condition that may be associated with a prolonged&#xD;
               bleeding time.&#xD;
  &#xD;
            -  Receipt or scheduled receipt of any other approved or authorized vaccines within 14&#xD;
               days (for all non-live vaccines or oral live vaccines) or 28 days (for parenteral live&#xD;
               vaccines) before or after trial vaccine administration.&#xD;
  &#xD;
            -  Participation in any clinical trial with another investigational product 30 days prior&#xD;
               to first trial visit or intention to participate in another clinical trial at any time&#xD;
               during the conduct of this trial.&#xD;
  &#xD;
            -  Seropositive for, or in evaluation for, possible human immunodeficiency virus&#xD;
               infection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Months</minimum_age>
      <maximum_age>5 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Clinical Lead</last_name>
      <phone>6172037722</phone>
      <email>clinical.trials@hillevax.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fukui Aiiku Hospital</name>
        <address>
          <city>Fukui-Shi</city>
          <zip>910-0833</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yukie Tamo</last_name>
        <phone>81776545757</phone>
        <email>tamo_y@sehma.co.jp</email>
      </contact>
      <investigator>
        <last_name>Yasunori Ishihara</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Iizuka Children's Clinic</name>
        <address>
          <city>Iizuka-Shi</city>
          <zip>820-0040</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tomoko Iwabuchi</last_name>
        <phone>817064827955</phone>
        <email>Tomoko-iwafuchi@cmicgroup.com</email>
      </contact>
      <investigator>
        <last_name>Hiromi Muta</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Childrens Clinic of Kose</name>
        <address>
          <city>Kofu-Shi</city>
          <zip>400-0853</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kumi Nakazawa</last_name>
        <phone>817041129230</phone>
        <email>nakazawa.kumi452@eps.co.jp</email>
      </contact>
      <investigator>
        <last_name>Mikiko Takano</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ohigesenseino Kodomo Clinic</name>
        <address>
          <city>Sapporo-Shi</city>
          <zip>062-0907</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rieko Goda</last_name>
        <phone>817064879875</phone>
        <email>rieko-goda@cmicgroup.com</email>
      </contact>
      <investigator>
        <last_name>Motoharu Yonekawa</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroenteritis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007781
  org study id: NOR-109
  nct id: NCT06007781
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This is a phase 1, randomized, double-blind multi-center, placebo-controlled trial in Japan
        to evaluate the safety and immunogenicity of HIL-214 in healthy infants 5 months of age
        (-14/+14 days) at first trial vaccine administration. In this protocol, because the trial is
        blinded, trial vaccine refers to both the investigational vaccine (HIL-214) and placebo.
  The rationale for trial NOR-109 is to evaluate the safety and immunogenicity of HIL-214 in
        Japanese pediatric subjects and establish whether the data obtained is consistent with that
        previously obtained for non-Japanese pediatric subjects.
  
        The clinical trials for HIL-214 have so far been performed in Europe, the United States and
        several countries in Latin America [26]. The incidence rate of norovirus-attributable disease
        in Japan is at least as high as in other developed countries with the highest rates occurring
        in children below the age of 5 years and hospitalization most common in very young and very
        old populations. The inclusion of infants (5 months [±14 days] of age at the time of first
        trial vaccine administration) serves to compare the data obtained for infants of non-Japanese
        descent with Japanese infants, in alignment with the global clinical program, and to support
        the inclusion of Japanese infants into phase 3. Enrollment and vaccination of the infants
        will be performed either before or after the required routine childhood vaccines per the
        national immunization schedule.
  
        This phase 1 trial in Japan aims to assess the safety and immunogenicity of two doses of
        HIL-214 administered 4 to 8 weeks apart, in 21 healthy infants aged 5 months at the time of
        the first trial vaccine dose administration. A placebo arm is included to allow an unbiased
        assessment of safety and immunogenicity.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Subjects will be allocated (2 to1) into one of two trial arms, Arm 1 - One dose of HIL-214; Arm 2 - One dose of placebo.
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Primary Objective
  time frame: 3 months
  description: All of the subjects in this trial will be assessed for safety of HIL-214 by comparing the occurrence and intensity of solicited and unsolicited local and systemic reactions to the study vaccine compared with placebo vaccination and including AEs leading to withdrawal of trial vaccine.
  measure: Number of subjects with solicited local AEs
  time frame: up to 7 days post-dose 1 and dose 2.
  description: Subjects that present with solicited systemic AEs.
  measure: Number of subjects with solicited Systemic AEs
  time frame: up to 7 days post-dose 1 and dose 2.
  description: Subjects that present with solicited systemic AEs.
  measure: Number of subjects with unsolicited symptomatic AEs
  time frame: up to 28 days post-dose 1 and dose 2.
  description: Subjects that present with unsolicited symptoms (AEs)
  measure: Number of subjects with AEs leading to withdrawal
  time frame: Up to 56 days post-dose 1
  description: The number of AEs that lead to vaccine dose withdrawal.
  measure: Number of subjects with Adverse Events and Serious Adverse Events
  time frame: Through study completion, an average of 1 year.
  description: The number of AEs and SAEs that lead to the subject's withdrawal from the trial
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
  arm group label: Experimental
  arm group type: Experimental
  description: One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57
  intervention type: Biological
  intervention name: Placebo
  description: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
  arm group label: Placebo
  intervention type: Biological
  intervention name: HIL-214
  description: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: 5 Months
  maximum age: 5 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Clinical Lead
  phone: 6172037722
  email: clinical.trials@hillevax.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Japan
  responsible party type: Sponsor
  mesh term: Gastroenteritis