<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/NCT02968173</url>
  </required_header>
  <id_info>
    <org_study_id>M15-539</org_study_id>
    <secondary_id>2016-000221-39</secondary_id>
    <nct_id>NCT02968173</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus</brief_title>
  <acronym>Synagis Russia</acronym>
  <official_title>A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the&#xD;
      safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of&#xD;
      the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants&#xD;
      at high risk (infants born at less than or equal to 35 weeks gestational age and less than or&#xD;
      equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age&#xD;
      with a diagnosis of chronic lung disease [CLD] of prematurity requiring on-going medical&#xD;
      treatment within the previous 6 months or infants less than or equal to 24 months of age with&#xD;
      hemodynamically significant congenital heart disease [CHD]).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will receive palivizumab solution for injection at 15 mg/kg by IM injection&#xD;
      every 30 days for a minimum of 3 and a maximum of 5 injections given during anticipated&#xD;
      periods of RSV risk in the community; the number of doses will depend on the time of&#xD;
      enrollment during the RSV season.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2016</start_date>
  <completion_date type="Actual">July 13, 2017</completion_date>
  <primary_completion_date type="Actual">July 13, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With RSV Hospitalization</measure>
    <time_frame>Approximately 6 months</time_frame>
    <description>An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Number of RSV-Hospitalization Days</measure>
    <time_frame>Approximately 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Received Supplemental Oxygen While Hospitalized</measure>
    <time_frame>Approximately 6 months</time_frame>
    <description>Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement</measure>
    <time_frame>Approximately 6 months</time_frame>
    <description>Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization</measure>
    <time_frame>Approximately 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Days of RSV-ICU Stay</measure>
    <time_frame>Approximately 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Received Mechanical Ventilation</measure>
    <time_frame>Approximately 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Days of Mechanical Ventilation During RSV-hospitalization</measure>
    <time_frame>Approximately 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Respiratory Syncytial Virus (RSV)</condition>
  <arm_group>
    <arm_group_label>Children at High Risk of severe RSV Infection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single IM injection every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palivizumab</intervention_name>
    <description>Palivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV.</description>
    <arm_group_label>Children at High Risk of severe RSV Infection</arm_group_label>
    <other_name>Synagis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Infants at high risk of severe RSV infection defined as fulfilling at least one of the&#xD;
        following:&#xD;
&#xD;
          -  Infants born ≤ 35 weeks gestational age AND are ≤ 6 months of age at enrollment&#xD;
&#xD;
          -  Infants ≤ 24 months of age at enrollment AND with a diagnosis of bronchopulmonary&#xD;
             dysplasia (BPD) (defined as oxygen requirement at a corrected gestational age of 36&#xD;
             weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators,&#xD;
             corticosteroids, etc.) anytime within 6 months prior to enrollment&#xD;
&#xD;
          -  Infants ≤ 24 months of age at enrollment with hemodynamically significant CHD, either&#xD;
             cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic&#xD;
             cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the&#xD;
             pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage&#xD;
             hemodynamically significant CHD&#xD;
&#xD;
        Exclusion Criteria (main exclusion criteria):&#xD;
&#xD;
          -  Hospitalization at the time of enrollment (unless discharge is anticipated within 14&#xD;
             days)&#xD;
&#xD;
          -  Mechanical ventilation (including continuous positive airway pressure, CPAP) at the&#xD;
             time of enrollment&#xD;
&#xD;
          -  Life expectancy less than 6 months&#xD;
&#xD;
          -  Unstable cardiac or respiratory status, including cardiac defects so severe that&#xD;
             survival is not expected or for which cardiac transplantation is planned or&#xD;
             anticipated&#xD;
&#xD;
          -  Active respiratory illness, or other acute infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joaquin Valdes</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>Belarus</country>
    <country>Russian Federation</country>
  </removed_countries>
  <link>
    <url>http://dailymed.nlm.nih.gov/dailymed/about.cfm</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>February 9, 2018</results_first_submitted>
  <results_first_submitted_qc>February 9, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 13, 2018</results_first_posted>
  <last_update_submitted>February 9, 2018</last_update_submitted>
  <last_update_submitted_qc>February 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bronchopulmonary dysplasia (BPD)</keyword>
  <keyword>RSV hospitalization</keyword>
  <keyword>Palivizumab</keyword>
  <keyword>Immunoprophylaxis</keyword>
  <keyword>Chronic lung disease (CLD) of prematurity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Palivizumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <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>January 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT02968173/SAP_000.pdf</document_url>
    </provided_document>
    <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>May 25, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT02968173/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Children at High Risk of Severe RSV Infection</title>
          <description>A single intramuscular (IM) injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the respiratory syncytial virus (RSV) season a participant was enrolled.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Children at High Risk of Severe RSV Infection</title>
          <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.22" spread="4.428"/>
                  </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="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With RSV Hospitalization</title>
        <description>An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).</description>
        <time_frame>Approximately 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Children at High Risk of Severe RSV Infection</title>
            <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With RSV Hospitalization</title>
          <description>An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of RSV-Hospitalization Days</title>
        <time_frame>Approximately 6 months</time_frame>
        <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
        <group_list>
          <group group_id="O1">
            <title>Children at High Risk of Severe RSV Infection</title>
            <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of RSV-Hospitalization Days</title>
          <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Received Supplemental Oxygen While Hospitalized</title>
        <description>Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.</description>
        <time_frame>Approximately 6 months</time_frame>
        <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
        <group_list>
          <group group_id="O1">
            <title>Children at High Risk of Severe RSV Infection</title>
            <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Received Supplemental Oxygen While Hospitalized</title>
          <description>Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.</description>
          <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement</title>
        <description>Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.</description>
        <time_frame>Approximately 6 months</time_frame>
        <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
        <group_list>
          <group group_id="O1">
            <title>Children at High Risk of Severe RSV Infection</title>
            <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.</description>
          </group>
        </group_list>
        <measure>
          <title>Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement</title>
          <description>Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.</description>
          <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization</title>
        <time_frame>Approximately 6 months</time_frame>
        <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
        <group_list>
          <group group_id="O1">
            <title>Children at High Risk of Severe RSV Infection</title>
            <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization</title>
          <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Days of RSV-ICU Stay</title>
        <time_frame>Approximately 6 months</time_frame>
        <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
        <group_list>
          <group group_id="O1">
            <title>Children at High Risk of Severe RSV Infection</title>
            <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Days of RSV-ICU Stay</title>
          <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Received Mechanical Ventilation</title>
        <time_frame>Approximately 6 months</time_frame>
        <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
        <group_list>
          <group group_id="O1">
            <title>Children at High Risk of Severe RSV Infection</title>
            <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Received Mechanical Ventilation</title>
          <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Days of Mechanical Ventilation During RSV-hospitalization</title>
        <time_frame>Approximately 6 months</time_frame>
        <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
        <group_list>
          <group group_id="O1">
            <title>Children at High Risk of Severe RSV Infection</title>
            <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Days of Mechanical Ventilation During RSV-hospitalization</title>
          <population>All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study treatment through the last prophylaxis visit (up to Day 120 [±5 days]) + 30 days (+5 days) and 100 days (+5 days)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PALIVIZUMAB TEAE Within 30 Days</title>
          <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.&#xD;
Treatment-emergent adverse events (TEAEs) are defined as those that began after the first dose of study drug but within 30 days (+ 30 day assessment period) after the last dose of study drug.</description>
        </group>
        <group group_id="E2">
          <title>PALIVIZUMAB TEAE Within 100 Days</title>
          <description>A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.&#xD;
TEAEs are defined as those that began after the first dose of study drug but within 100 days (+ 100 day assessment period) after the last dose of study drug.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</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="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia paroxysmal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Bronchitis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Haemangioma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </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="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT02968173
org study id: M15-539
secondary id: 2016-000221-39
nct id: NCT02968173
lead sponsor: 
has dmc: No
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the
      safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of
      the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants
      at high risk (infants born at less than or equal to 35 weeks gestational age and less than or
      equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age
      with a diagnosis of chronic lung disease [CLD] of prematurity requiring on-going medical
      treatment within the previous 6 months or infants less than or equal to 24 months of age with
      hemodynamically significant congenital heart disease [CHD]).
Participants will receive palivizumab solution for injection at 15 mg/kg by IM injection
      every 30 days for a minimum of 3 and a maximum of 5 injections given during anticipated
      periods of RSV risk in the community; the number of doses will depend on the time of
      enrollment during the RSV season.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With RSV Hospitalization
time frame: Approximately 6 months
description: An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).
measure: Total Number of RSV-Hospitalization Days
time frame: Approximately 6 months
measure: Percentage of Participants Who Received Supplemental Oxygen While Hospitalized
time frame: Approximately 6 months
description: Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.
measure: Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement
time frame: Approximately 6 months
description: Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.
measure: Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization
time frame: Approximately 6 months
measure: Total Days of RSV-ICU Stay
time frame: Approximately 6 months
measure: Percentage of Participants Who Received Mechanical Ventilation
time frame: Approximately 6 months
measure: Total Days of Mechanical Ventilation During RSV-hospitalization
time frame: Approximately 6 months
arm group label: Children at High Risk of severe RSV Infection
arm group type: Experimental
description: A single IM injection every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
intervention type: Drug
intervention name: Palivizumab
description: Palivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV.
arm group label: Children at High Risk of severe RSV Infection
other name: Synagis
criteria: 
gender: All
minimum age: N/A
maximum age: 24 Months
healthy volunteers: No
last name: Joaquin Valdes
role: Study Director
affiliation: AbbVie
country: Belarus
country: Russian Federation
url: http://dailymed.nlm.nih.gov/dailymed/about.cfm
description: Related Info
responsible party type: Sponsor
mesh term: Infections
mesh term: Virus Diseases
mesh term: Palivizumab
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 