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/NCT06042049</url>
    </required_header>
    <id_info>
      <org_study_id>D5290C00009</org_study_id>
      <nct_id>NCT06042049</nct_id>
    </id_info>
    <brief_title>A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab</brief_title>
    <acronym>JUBILUS</acronym>
    <official_title>A Phase III Single-Arm Open-Label Study to Evaluate the Safety PK ADA and Anti RSV nAb Following Administration of 2 Doses of Nirsevimab Given 5 to 6 Months Apart in Infants With CHD, CLD, Immunocompromise, Down Syndrome, or Born Pre-Term in Japan</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Iqvia Pty Ltd</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>AstraZeneca</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and&#xD;
        anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term&#xD;
        infants aged ≤12 months.&#xD;
  &#xD;
        Study details include&#xD;
  &#xD;
          -  The study duration is approximately 21 months with a 2-month enrollment period.&#xD;
  &#xD;
          -  Study intervention is 2 doses administered 5- 6 months apart.&#xD;
  &#xD;
          -  The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week&#xD;
             interval&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 27, 2023</start_date>
    <completion_date type="Anticipated">April 23, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 23, 2025</primary_completion_date>
    <phase>Phase 3</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>
      <masking_description>No masking is used. All involved know the identity of the intervention assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of all TEAEs, TESAEs, AESIs, and NOCDs</measure>
      <time_frame>360 days after the 2nd or last dose administered in the study</time_frame>
      <description>The number and percentage of participants with TEAEs, TESAEs, AESIs, and NOCDs will be summarized by SOC and PT overall.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Study discontinuations prior to Day 151 post 2nd dose.</measure>
      <time_frame>360 days after the 2nd or last dose administered in the study</time_frame>
      <description>The number and percentage of subject discontinuations will be summarized.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics (PK) - Nirsevimab serum concentrations</measure>
      <time_frame>360 days after the 2nd or last dose administered in the study</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ADA - Occurrence of ADA to nirsevimab in serum</measure>
      <time_frame>360 days after the 2nd or last dose administered in the study</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-RSV neutralizing Ab - Anti-RSV neutralizing Ab levels (IU/mL) in serum</measure>
      <time_frame>360 days after the 2nd or last dose administered in the study</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>MA-RSV LRTI - Occurrence of MA-LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV</measure>
      <time_frame>through 150 and 360 days post 2nd dose</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>MA-RSV LRTI - Occurrence of hospitalizations due to RT-PCR-confirmed RSV</measure>
      <time_frame>through 150 and 360 days post 2nd dose</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Monitoring for RSV Resistance - Genotypic analysis of the F protein from collected RSV-positive respiratory secretion specimens</measure>
      <time_frame>through 150 and 360 days post 2nd dose</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Monitoring RSV Resistance to Nirsevimab - RSV novel variants will be phenotypically characterized for nirsevimab susceptibility</measure>
      <time_frame>through 150 and 360 days post 2nd dose</time_frame>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">33</enrollment>
    <condition>Respiratory Syncytial Virus Infections</condition>
    <arm_group>
      <arm_group_label>MEDI8897</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Anti-RSV monoclonal antibody</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nirsevimab</intervention_name>
      <description>Participants in the first year of life will receive the 1st dose of nirsevimab as a single, fixed intramuscular (IM) dose of 50 mg if body weight is &lt;5 kg or 100 mg if body weight is ≥5 kg. A 2nd fixed IM dose of 50 mg if body weight is &lt;5 kg or 100 mg if body weight is ≥5 kg will be administered 5 to 6 months following the 1st dose.</description>
      <arm_group_label>MEDI8897</arm_group_label>
      <other_name>MEDI8897</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written informed consent and any locally required authorization obtained from the&#xD;
               participant's parent(s)/legally authorized representative(s) before performing any&#xD;
               protocol-related procedures, including screening evaluations&#xD;
  &#xD;
            2. Japanese infants of ≤12 months of age eligible to receive palivizumab in accordance&#xD;
               with national or local guidelines and those who must meet at least one of the&#xD;
               following conditions at the time of informed consent.&#xD;
  &#xD;
                 1. Immunodeficiency&#xD;
  &#xD;
                 2. Chronic Lung Disease&#xD;
  &#xD;
                 3. Congenital Heart Disease&#xD;
  &#xD;
                 4. Down syndrome&#xD;
  &#xD;
                 5. Born pre-term ≤28 wks Gestation age and aged ≤12 months, or born pre-term &gt;28 wks&#xD;
                    and ≤35 wks Gestation age and aged ≤6 months&#xD;
  &#xD;
            3. The participant's parent(s)/legally authorized representative(s) can understand and&#xD;
               comply with the requirements of the protocol including follow-up visits as judged by&#xD;
               the investigator.&#xD;
  &#xD;
            4. The participant is available to complete the follow-up period for approximately 19&#xD;
               months, which will be approximately 1 year after receipt of 2nd dose of nirsevimab&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Requirement for mechanical ventilation, extracorporeal membrane oxygenation,&#xD;
               continuous positive airway pressure (CPAP), or other mechanical respiratory or cardiac&#xD;
               support at the time of enrollment&#xD;
  &#xD;
            2. A current, active RSV infection at the time of screening and investigational product&#xD;
               administration&#xD;
  &#xD;
            3. Any fever (≥100.4°F [≥38.0°C], regardless of route) or acute illness at the time of&#xD;
               prior to investigational product administration&#xD;
  &#xD;
            4. Any serious concurrent medical condition (except those resulting in an immune&#xD;
               deficiency condition), including:&#xD;
  &#xD;
                 1. Known renal impairment&#xD;
  &#xD;
                 2. Known hepatic dysfunction including known or suspected active or chronic&#xD;
                    hepatitis infection&#xD;
  &#xD;
                 3. Any seizure disorder or evolving or unstable neurological condition&#xD;
  &#xD;
            5. Anticipated cardiac surgery within 5-6 months after enrollment&#xD;
  &#xD;
            6. Prior history of a suspected or actual acute life-threatening event&#xD;
  &#xD;
            7. Receipt or intended use of palivizumab in the current enrollment season&#xD;
  &#xD;
            8. Any known allergy or history of allergic reaction to any component of nirsevimab&#xD;
  &#xD;
            9. Any known allergy or history of allergic reaction to immunoglobulin products, blood&#xD;
               products, or other foreign proteins&#xD;
  &#xD;
           10. Concurrent enrollment in another interventional study, or prior receipt of any&#xD;
               investigational agent&#xD;
  &#xD;
           11. Anticipated survival of less than 1 year at the time of informed consent&#xD;
  &#xD;
           12. Any condition that, in the opinion of the investigator, would interfere with the&#xD;
               evaluation of the investigational product or interpretation of study results&#xD;
  &#xD;
           13. Children of employees of the Sponsor, clinical study site, or any other individuals&#xD;
               involved with the conduct of the study, or immediate family members of such&#xD;
               individuals&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>1 Year</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>AstraZeneca Clinical Study Information Center</last_name>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Bunkyo-ku</city>
          <zip>113-8519</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Fuchu-shi</city>
          <zip>183-8561</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Fukuoka-shi</city>
          <zip>813-0017</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Kitakyusyu-shi</city>
          <zip>806-8501</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Koto-ku</city>
          <zip>135-8577</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Kurume-shi</city>
          <zip>830-0011</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Maebashi-shi</city>
          <zip>371-0811</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Nagasaki-shi</city>
          <zip>852-8501</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Saitama-shi</city>
          <zip>336-8522</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Tsukuba-shi</city>
          <zip>305-8576</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Yokohama-shi</city>
          <zip>224-8503</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Yokohama-shi</city>
          <zip>232 8555</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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>Respiratory Syncytial Virus Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.&#xD;
  All request will be evaluated as per the AZ disclosure commitment:&#xD;
  https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
      <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
      <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
    </patient_data>
    <!-- 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/NCT06042049
  org study id: D5290C00009
  nct id: NCT06042049
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and
        anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term
        infants aged ≤12 months.
  
        Study details include
  
          -  The study duration is approximately 21 months with a 2-month enrollment period.
  
          -  Study intervention is 2 doses administered 5- 6 months apart.
  
          -  The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week
             interval
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  masking description: No masking is used. All involved know the identity of the intervention assignment.
  measure: Incidence of all TEAEs, TESAEs, AESIs, and NOCDs
  time frame: 360 days after the 2nd or last dose administered in the study
  description: The number and percentage of participants with TEAEs, TESAEs, AESIs, and NOCDs will be summarized by SOC and PT overall.
  measure: Study discontinuations prior to Day 151 post 2nd dose.
  time frame: 360 days after the 2nd or last dose administered in the study
  description: The number and percentage of subject discontinuations will be summarized.
  measure: Pharmacokinetics (PK) - Nirsevimab serum concentrations
  time frame: 360 days after the 2nd or last dose administered in the study
  measure: ADA - Occurrence of ADA to nirsevimab in serum
  time frame: 360 days after the 2nd or last dose administered in the study
  measure: Anti-RSV neutralizing Ab - Anti-RSV neutralizing Ab levels (IU/mL) in serum
  time frame: 360 days after the 2nd or last dose administered in the study
  measure: MA-RSV LRTI - Occurrence of MA-LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV
  time frame: through 150 and 360 days post 2nd dose
  measure: MA-RSV LRTI - Occurrence of hospitalizations due to RT-PCR-confirmed RSV
  time frame: through 150 and 360 days post 2nd dose
  measure: Monitoring for RSV Resistance - Genotypic analysis of the F protein from collected RSV-positive respiratory secretion specimens
  time frame: through 150 and 360 days post 2nd dose
  measure: Monitoring RSV Resistance to Nirsevimab - RSV novel variants will be phenotypically characterized for nirsevimab susceptibility
  time frame: through 150 and 360 days post 2nd dose
  arm group label: MEDI8897
  arm group type: Experimental
  description: Anti-RSV monoclonal antibody
  intervention type: Drug
  intervention name: Nirsevimab
  description: Participants in the first year of life will receive the 1st dose of nirsevimab as a single, fixed intramuscular (IM) dose of 50 mg if body weight is <5 kg or 100 mg if body weight is ≥5 kg. A 2nd fixed IM dose of 50 mg if body weight is <5 kg or 100 mg if body weight is ≥5 kg will be administered 5 to 6 months following the 1st dose.
  arm group label: MEDI8897
  other name: MEDI8897
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 1 Year
  healthy volunteers: No
  last name: AstraZeneca Clinical Study Information Center
  phone: 1-877-240-9479
  email: information.center@astrazeneca.com
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: Japan
  responsible party type: Sponsor
  mesh term: Respiratory Syncytial Virus Infections
  sharing ipd: Yes
  ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
  All request will be evaluated as per the AZ disclosure commitment:
  https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  ipd access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home