<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/NCT02989194</url>
  </required_header>
  <id_info>
    <org_study_id>VIS410-202</org_study_id>
    <nct_id>NCT02989194</nct_id>
  </id_info>
  <brief_title>Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A</brief_title>
  <official_title>A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of an Investigational Monoclonal Antibody With Code Name VIS410 in Subjects With Uncomplicated Influenza A Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Visterra, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biomedical Advanced Research and Development Authority</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Visterra, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the&#xD;
      safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with&#xD;
      uncomplicated influenza.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be admitted to an infusion unit for drug administration and observation&#xD;
      following infusion. The study is designed to compare an infusion of a single high or low IV&#xD;
      dose of VIS410 against placebo. Subjects will be followed for 100 (±7 days).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2017</start_date>
  <completion_date type="Actual">October 27, 2017</completion_date>
  <primary_completion_date type="Actual">October 27, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection</measure>
    <time_frame>100 days</time_frame>
    <description>The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest</measure>
    <time_frame>100 days</time_frame>
    <description>Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410</measure>
    <time_frame>10 days</time_frame>
    <description>The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group. The data below show the percent change in mean total symptom scores over time by treatment arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for Influenza-related Complications</measure>
    <time_frame>100 days</time_frame>
    <description>Number of participants requiring hospitalization for influenza-related complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Hospitalization for Complications of Influenza</measure>
    <time_frame>100 days</time_frame>
    <description>Duration of hospitalization for participants with at least 1 complication of influenza. There were no participants hospitalized for complications of influenza.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants With Complications of Influenza</measure>
    <time_frame>100 days</time_frame>
    <description>Count of participants with at least 1 complication of influenza</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influenza A Relapse/Reinfection</measure>
    <time_frame>100 days</time_frame>
    <description>Number of participants with influenza A relapse/reinfection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VIS410 Maximum Plasma Concentration</measure>
    <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
    <description>The maximum observed concentration of VIS410 in serum (Cmax).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of VIS410 Concentration in Serum</measure>
    <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
    <description>Time corresponding to the maximum serum concentration of VIS410.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VIS410 Plasma Concentration ( AUC 0-infinity)</measure>
    <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
    <description>VIS410 area under the plasma concentration time curve in serum. AUC 0-infinity is from the time of dosing extrapolated to infinity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VIS410 Plasma Concentration (AUC 0-last)</measure>
    <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
    <description>VIS410 area under the plasma concentration time curve in serum. AUC 0-last is the area under the plasma concentration time curve from time 0 to the last measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life of VIS410 in Serum.</measure>
    <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
    <description>Terminal elimination half-life of VIS410 in serum (t1/2) in serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance (CL) of VIS410 in Serum.</measure>
    <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
    <description>Summary of VIS410 total clearance (CL) in serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.</measure>
    <time_frame>7 days</time_frame>
    <description>The difference between VIS410 and placebo treatment groups in viral AUC based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Viral Load by TCID50</measure>
    <time_frame>7 days</time_frame>
    <description>The difference between VIS410 and placebo treatment groups in peak viral load based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.</measure>
    <time_frame>7 days</time_frame>
    <description>The number of days for the median time to resolution of peak viral load from end of infusion by nasopharyngeal swabs collected from the first 50 participants and tested by half maximal tissue culture infective dose (TCID50)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of Anti-VIS410 Antibody (ADA) Titers.</measure>
    <time_frame>100 days</time_frame>
    <description>Count of subjects testing positive for anti-VIS410 antibodies on days 1, 14, 56 and 100. A positive result includes samples confirmed positive and above titer cut point factor (and titer ≥ 1). Negative results include screened or confirmed negative or confirmed positive but below titer cut point factor (titer &lt; 1). For participants receiving placebo, only samples from two participants were tested at Days 14 and 56.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410</measure>
    <time_frame>10 days</time_frame>
    <description>The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. Data below show the time to symptom resolution for Total Symptom Score.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>VIS410 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravenous fixed low dose of VIS410</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VIS410 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravenous fixed high dose of VIS410</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single intravenous placebo infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VIS410 low dose</intervention_name>
    <description>Single intravenous fixed low dose of VIS410</description>
    <arm_group_label>VIS410 low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VIS410 high dose</intervention_name>
    <description>Single intravenous fixed high dose of VIS410</description>
    <arm_group_label>VIS410 high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single intravenous infusion of placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects aged ≥18 years and ˂65 years&#xD;
&#xD;
          -  Women should fulfill one of the following criteria:&#xD;
&#xD;
               1. Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone &gt;40&#xD;
                  mIU/mL (milli-international units/milliliter) as documented in their medical&#xD;
                  history&#xD;
&#xD;
               2. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation&#xD;
&#xD;
               3. Women of childbearing potential participating in heterosexual sexual relations&#xD;
                  must be willing to use adequate contraception from screening until 60 days post&#xD;
                  infusion&#xD;
&#xD;
          -  Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects&#xD;
             who have a female partner of childbearing potential must use an effective birth&#xD;
             control method when having heterosexual intercourse, from screening until 60 days post&#xD;
             infusion&#xD;
&#xD;
          -  Test positive for influenza A by Rapid Antigen Test performed with a commercially&#xD;
             available test on an adequate nasopharyngeal specimen in accordance with the&#xD;
             manufacturer's instructions&#xD;
&#xD;
          -  Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms)&#xD;
             of moderate to severe intensity, or presence of at least one constitutional symptom&#xD;
             (myalgia [aches and pains], headache, feverishness, or fatigue) of moderate to severe&#xD;
             intensity&#xD;
&#xD;
          -  Onset of symptoms (time when the temperature was first measured as elevated&#xD;
             [temperature of ≥100.4°F or ≥38°C], OR the time when the subject experienced at least&#xD;
             one respiratory symptom or at least one constitutional symptom) no more than 72 hours&#xD;
             before the start of infusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of NSAIDs or antihistamines within 6 hours of study drug dosing with the exception&#xD;
             of those used as part of the pretreatment regimen&#xD;
&#xD;
          -  History of intolerance or allergic response to monoclonal antibodies and/or&#xD;
             pretreatment medications (diphenhydramine, ibuprofen and acetylsalicylic acid)&#xD;
&#xD;
          -  Subject weight less than (&lt;) 45 kg&#xD;
&#xD;
          -  Subjects with clinical history that would lead to increased risk of influenza&#xD;
             complications including but not limited to clinically significant cardiac disease,&#xD;
             moderate to severe asthma, or other moderate to severe chronic obstructive pulmonary&#xD;
             disease, metabolic syndrome including moderate to severe diabetes or active&#xD;
             tuberculosis&#xD;
&#xD;
          -  History of chronic GI disease, including bleeding, ulceration, Irritable Bowel&#xD;
             Syndrome, systemic mastocytosis or chronic diarrhea&#xD;
&#xD;
          -  Women who are pregnant, breast-feeding, or considering becoming pregnant&#xD;
&#xD;
          -  Patients with hypoxemia requiring oxygen support&#xD;
&#xD;
          -  Clinical evidence of worsening of any chronic medical condition (temporally associated&#xD;
             with the onset of symptoms of influenza) which, in the Investigator's opinion,&#xD;
             indicates that such finding(s) could represent complications of influenza&#xD;
&#xD;
          -  Presence of immunocompromised status due to chronic illness, previous organ&#xD;
             transplant, or use of immunosuppressive medical therapy including systemic steroids&#xD;
&#xD;
          -  Presence of known Acquired Immune Deficiency Syndrome-defining illness, chronic&#xD;
             hepatitis B or hepatitis C&#xD;
&#xD;
          -  Receipt of any dose of antiviral therapy such as, but not limited to, rimantadine,&#xD;
             amantadine, peramivir, zanamivir, laninamivir or oseltamivir in the 7 days prior to&#xD;
             screening&#xD;
&#xD;
          -  Enrollment in any other investigational drug or device study, any disease or vaccine&#xD;
             study within 30 days prior to Day 1 or within 5 half-lives of the investigational&#xD;
             compound, whichever is longer&#xD;
&#xD;
          -  Subjects unable to take oral predose medication&#xD;
&#xD;
          -  Known or suspected alcohol or drug abuse, that is, abuse of a level that would&#xD;
             compromise the safety or cooperation of the subject in the opinion of the Investigator&#xD;
&#xD;
          -  Subjects on chronic medications where the dose has not been stable for at least 3&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development</last_name>
    <role>Study Director</role>
    <affiliation>Visterra, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Homestead</city>
        <state>Florida</state>
        <zip>33033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33185</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32811</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Eunice</city>
        <state>Louisiana</state>
        <zip>70535</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <zip>28150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Asenovgrad</city>
        <zip>4230</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lom</city>
        <zip>3600</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sofia</city>
        <zip>1202</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Velingrad</city>
        <zip>4600</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paide</city>
        <zip>72713</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tallinn</city>
        <zip>10617</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tallinn</city>
        <zip>11615</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tallinn</city>
        <zip>13415</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daugavpils</city>
        <zip>LV-5417</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liepaja</city>
        <zip>LV-3414</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rezekne</city>
        <zip>LV-4600</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Riga</city>
        <zip>LV-1010</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valmiera</city>
        <zip>LV-4201</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ventspils</city>
        <zip>LV-3601</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nis</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Novi Sad</city>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Welkom</city>
        <state>Free State</state>
        <zip>9460</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Benoni</city>
        <state>Gauteng</state>
        <zip>1500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Centurion</city>
        <state>Gauteng</state>
        <zip>1692</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2113</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kempton Park</city>
        <state>Gauteng</state>
        <zip>1619</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pretoria West</city>
        <state>Gauteng</state>
        <zip>0183</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0121</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Soshanguve</city>
        <state>Gauteng</state>
        <zip>0152</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Soweto</city>
        <state>Gauteng</state>
        <zip>2013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durban</city>
        <state>Kwazulu Natal</state>
        <zip>4092</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Thabazimbi</city>
        <state>Limpopo</state>
        <zip>0380</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Middelburg</city>
        <state>Mpumalanga</state>
        <zip>1055</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Witbank</city>
        <state>Mpumalanga</state>
        <zip>1035</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7570</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Worcester</city>
        <state>Western Cape</state>
        <zip>6850</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kharkiv</city>
        <zip>61064</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kharkiv</city>
        <zip>61106</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kiev</city>
        <zip>03049</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kiev</city>
        <zip>03110</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kiev</city>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Odesa</city>
        <zip>65023</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sumy</city>
        <zip>40021</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vinnytsya</city>
        <zip>21001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vinnytsya</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Estonia</country>
    <country>Latvia</country>
    <country>Serbia</country>
    <country>South Africa</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Hershberger E, Sloan S, Narayan K, Hay CA, Smith P, Engler F, Jeeninga R, Smits S, Trevejo J, Shriver Z, Oldach D. Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study. EBioMedicine. 2019 Feb;40:574-582. doi: 10.1016/j.ebiom.2018.12.051. Epub 2019 Jan 9.</citation>
    <PMID>30638863</PMID>
  </results_reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <results_first_submitted>May 20, 2020</results_first_submitted>
  <results_first_submitted_qc>August 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 15, 2022</results_first_posted>
  <last_update_submitted>August 11, 2022</last_update_submitted>
  <last_update_submitted_qc>August 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</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>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans to share IPD</ipd_description>
  </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 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT02989194/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>January 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT02989194/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was initiated in 58 study centers; 28 sites enrolled at least 1 subject.</recruitment_details>
      <pre_assignment_details>When required, subject may have been given a pre-screening informed consent to perform a Rapid Antigen Test for influenza. Flu-positive subjects were given a full explanation of the nature of the study and written informed consent (approved by local ethics committee) was obtained according to local requirements before any study related assessments</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>VIS410 High Dose</title>
          <description>Single intravenous fixed dose of 4000 mg VIS410</description>
        </group>
        <group group_id="P2">
          <title>VIS410 Low Dose</title>
          <description>Single intravenous fixed dose of 2000 mg VIS410</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Single intravenous saline solution</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 group_id="P2" count="50"/>
                <participants group_id="P3" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study on hold for safety and participant was withdrawn</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>VIS410 High Dose</title>
          <description>Single intravenous fixed dose of 4000 mg VIS410</description>
        </group>
        <group group_id="B2">
          <title>VIS410 Low Dose</title>
          <description>Single intravenous fixed dose of 2000 mg VIS410</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Single intravenous saline solution</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="50"/>
            <count group_id="B4" value="150"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="150"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.3" spread="13.13"/>
                    <measurement group_id="B2" value="39.6" spread="13.79"/>
                    <measurement group_id="B3" value="43.1" spread="12.77"/>
                    <measurement group_id="B4" value="41.0" spread="13.23"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="66"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Latvia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Estonia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Subjects Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.01" lower_limit="19.4" upper_limit="48.0"/>
                    <measurement group_id="B2" value="30.80" lower_limit="16.7" upper_limit="55.6"/>
                    <measurement group_id="B3" value="28.82" lower_limit="18.0" upper_limit="43.1"/>
                    <measurement group_id="B4" value="29.54" lower_limit="16.7" upper_limit="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time since onset of influenza (hours)</title>
          <population>Participant was omitted if the date/time of symptom onset was missing.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="49"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.31" spread="16.479"/>
                    <measurement group_id="B2" value="40.57" spread="11.563"/>
                    <measurement group_id="B3" value="38.19" spread="13.859"/>
                    <measurement group_id="B4" value="40.67" spread="14.170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time since onset of influenza (hours)</title>
          <description>Median time since onset of influenza in hours.</description>
          <population>Participants who did not have a start date/time for symptom onset were excluded.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="49"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.69" lower_limit="19.4" upper_limit="48.0"/>
                    <measurement group_id="B2" value="28.88" lower_limit="16.7" upper_limit="55.6"/>
                    <measurement group_id="B3" value="28.07" lower_limit="18.0" upper_limit="43.1"/>
                    <measurement group_id="B4" value="28.60" lower_limit="16.7" upper_limit="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection</title>
        <description>The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.</description>
        <time_frame>100 days</time_frame>
        <population>Safety Population The safety population included all subjects randomized who received IV study drug. The safety population summaries were based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Summation of the VIS410 high and low dose groups.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous dose of saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection</title>
          <description>The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.</description>
          <population>Safety Population The safety population included all subjects randomized who received IV study drug. The safety population summaries were based on the actual treatment received.</population>
          <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="49"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="98"/>
                <count group_id="O4" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of subjects with any adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1" lower_limit="42.21" upper_limit="71.18"/>
                    <measurement group_id="O2" value="34.7" lower_limit="21.67" upper_limit="49.64"/>
                    <measurement group_id="O3" value="45.9" lower_limit="35.80" upper_limit="56.29"/>
                    <measurement group_id="O4" value="26.0" lower_limit="14.63" upper_limit="40.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of subjects with any serious adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="7.25"/>
                    <measurement group_id="O2" value="0" lower_limit="0.00" upper_limit="7.25"/>
                    <measurement group_id="O3" value="0" lower_limit="0.0" upper_limit="3.69"/>
                    <measurement group_id="O4" value="4" lower_limit="0.49" upper_limit="13.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest</title>
        <description>Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.</description>
        <time_frame>100 days</time_frame>
        <population>Safety Population. The safety population included all participants randomized who received IV study drug. The safety population summaries were based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>Total VIS410</title>
            <description>Summation of 4000 mg and 2000 mg VIS410 dose groups.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest</title>
          <description>Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.</description>
          <population>Safety Population. The safety population included all participants randomized who received IV study drug. The safety population summaries were based on the actual treatment received.</population>
          <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="49"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="98"/>
                <count group_id="O4" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of subjects with any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.1" lower_limit="40.23" upper_limit="69.33"/>
                    <measurement group_id="O2" value="34.7" lower_limit="21.67" upper_limit="49.64"/>
                    <measurement group_id="O3" value="44.9" lower_limit="34.83" upper_limit="55.28"/>
                    <measurement group_id="O4" value="24.0" lower_limit="13.06" upper_limit="38.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of subjects with treatment related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6" lower_limit="18.25" upper_limit="45.42"/>
                    <measurement group_id="O2" value="14.3" lower_limit="5.94" upper_limit="27.24"/>
                    <measurement group_id="O3" value="22.4" lower_limit="14.64" upper_limit="31.99"/>
                    <measurement group_id="O4" value="12.0" lower_limit="4.53" upper_limit="24.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of subjects with any TEAEs of Special Interest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.7" lower_limit="21.67" upper_limit="49.64"/>
                    <measurement group_id="O2" value="16.3" lower_limit="7.32" upper_limit="29.66"/>
                    <measurement group_id="O3" value="25.5" lower_limit="17.24" upper_limit="35.31"/>
                    <measurement group_id="O4" value="12" lower_limit="4.53" upper_limit="24.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Subjects with any hypersensitivity Reactions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="7.25"/>
                    <measurement group_id="O2" value="0" lower_limit="0.00" upper_limit="7.25"/>
                    <measurement group_id="O3" value="0" lower_limit="0.00" upper_limit="3.69"/>
                    <measurement group_id="O4" value="0" lower_limit="0.00" upper_limit="7.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of subjects with any anaphylactic reactions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="7.25"/>
                    <measurement group_id="O2" value="0" lower_limit="0.00" upper_limit="7.25"/>
                    <measurement group_id="O3" value="0" lower_limit="0.00" upper_limit="3.69"/>
                    <measurement group_id="O4" value="0" lower_limit="0.00" upper_limit="7.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of subjects with any injection site AEs.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="0.05" upper_limit="10.85"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.00" upper_limit="7.25"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0.03" upper_limit="5.55"/>
                    <measurement group_id="O4" value="0" lower_limit="0.00" upper_limit="7.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410</title>
        <description>The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group. The data below show the percent change in mean total symptom scores over time by treatment arm.</description>
        <time_frame>10 days</time_frame>
        <population>Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Summation of the 4000 and 2000 mg dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single dose intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410</title>
          <description>The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group. The data below show the percent change in mean total symptom scores over time by treatment arm.</description>
          <population>Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="90"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent Change from Baseline to Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.12" spread="27.00"/>
                    <measurement group_id="O2" value="-29.98" spread="29.55"/>
                    <measurement group_id="O3" value="-28.01" spread="28.18"/>
                    <measurement group_id="O4" value="-19.53" spread="26.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage change from baseline to day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.65" spread="28.78"/>
                    <measurement group_id="O2" value="-49.37" spread="29.62"/>
                    <measurement group_id="O3" value="-43.89" spread="29.53"/>
                    <measurement group_id="O4" value="-33.63" spread="23.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage change from baseline to day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.46" spread="26.16"/>
                    <measurement group_id="O2" value="-59.08" spread="31.12"/>
                    <measurement group_id="O3" value="-56.21" spread="28.67"/>
                    <measurement group_id="O4" value="-44.55" spread="28.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage change from baseline to day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-60.85" spread="25.52"/>
                    <measurement group_id="O2" value="-64.61" spread="29.91"/>
                    <measurement group_id="O3" value="-62.69" spread="27.66"/>
                    <measurement group_id="O4" value="-56.75" spread="24.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage change from baseline to day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-69.31" spread="20.90"/>
                    <measurement group_id="O2" value="-66.80" spread="33.42"/>
                    <measurement group_id="O3" value="-68.08" spread="27.61"/>
                    <measurement group_id="O4" value="64.01" spread="23.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage change from baseline to day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-74.03" spread="19.31"/>
                    <measurement group_id="O2" value="-70.76" spread="31.18"/>
                    <measurement group_id="O3" value="-72.43" spread="25.71"/>
                    <measurement group_id="O4" value="-71.51" spread="20.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage change from baseline to day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-77.98" spread="20.76"/>
                    <measurement group_id="O2" value="-76.03" spread="25.53"/>
                    <measurement group_id="O3" value="-77.02" spread="23.13"/>
                    <measurement group_id="O4" value="-76.16" spread="21.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage change from baseline to day 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-80.05" spread="19.78"/>
                    <measurement group_id="O2" value="-78.48" spread="25.95"/>
                    <measurement group_id="O3" value="-79.27" spread="22.91"/>
                    <measurement group_id="O4" value="-79.52" spread="19.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage change from baseline to day 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-82.30" spread="20.07"/>
                    <measurement group_id="O2" value="-81.38" spread="20.43"/>
                    <measurement group_id="O3" value="-81.85" spread="20.14"/>
                    <measurement group_id="O4" value="-84.35" spread="17.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Change from Baseline to Day 2. All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.158</p_value>
            <p_value_desc>All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Change from Baseline to Day 3. All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.025</p_value>
            <p_value_desc>All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Change from Baseline to Day 4. All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.007</p_value>
            <p_value_desc>All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Change from Baseline to Day 5. All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.061</p_value>
            <p_value_desc>All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Change from Baseline to Day 6. All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.107</p_value>
            <p_value_desc>All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Change from Baseline to Day 7. All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.237</p_value>
            <p_value_desc>All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Change from Baseline to Day 8. All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.497</p_value>
            <p_value_desc>All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Change from Baseline to Day 9. All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.704</p_value>
            <p_value_desc>All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Change from Baseline to Day 10. All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.585</p_value>
            <p_value_desc>All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospitalization for Influenza-related Complications</title>
        <description>Number of participants requiring hospitalization for influenza-related complications</description>
        <time_frame>100 days</time_frame>
        <population>Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Summation of 4000 and 2000 mg VIS410 dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalization for Influenza-related Complications</title>
          <description>Number of participants requiring hospitalization for influenza-related complications</description>
          <population>Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="90"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Hospitalization for Complications of Influenza</title>
        <description>Duration of hospitalization for participants with at least 1 complication of influenza. There were no participants hospitalized for complications of influenza.</description>
        <time_frame>100 days</time_frame>
        <population>Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Summation of 4000 and 2000 mg VIS410 dose groups.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Hospitalization for Complications of Influenza</title>
          <description>Duration of hospitalization for participants with at least 1 complication of influenza. There were no participants hospitalized for complications of influenza.</description>
          <population>Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="90"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants With Complications of Influenza</title>
        <description>Count of participants with at least 1 complication of influenza</description>
        <time_frame>100 days</time_frame>
        <population>Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Summation of 4000 and 2000 mg VIS410 dose groups.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With Complications of Influenza</title>
          <description>Count of participants with at least 1 complication of influenza</description>
          <population>Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
          <units>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="46"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="90"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0.06" upper_limit="11.53"/>
                    <measurement group_id="O2" value="3" lower_limit="1.43" upper_limit="18.66"/>
                    <measurement group_id="O3" value="4" lower_limit="1.22" upper_limit="10.99"/>
                    <measurement group_id="O4" value="3" lower_limit="1.31" upper_limit="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influenza A Relapse/Reinfection</title>
        <description>Number of participants with influenza A relapse/reinfection</description>
        <time_frame>100 days</time_frame>
        <population>Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Summation of 4000 and 2000 mg VIS410 dose groups.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Influenza A Relapse/Reinfection</title>
          <description>Number of participants with influenza A relapse/reinfection</description>
          <population>Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="90"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VIS410 Maximum Plasma Concentration</title>
        <description>The maximum observed concentration of VIS410 in serum (Cmax).</description>
        <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
        <population>The Pharmacokinetics (PK) population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
        </group_list>
        <measure>
          <title>VIS410 Maximum Plasma Concentration</title>
          <description>The maximum observed concentration of VIS410 in serum (Cmax).</description>
          <population>The Pharmacokinetics (PK) population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1013.559" spread="35.5"/>
                    <measurement group_id="O2" value="627.640" spread="54.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of VIS410 Concentration in Serum</title>
        <description>Time corresponding to the maximum serum concentration of VIS410.</description>
        <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
        <population>The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics of VIS410 Concentration in Serum</title>
          <description>Time corresponding to the maximum serum concentration of VIS410.</description>
          <population>The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated</population>
          <units>day</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.119" spread="79.0624"/>
                    <measurement group_id="O2" value="0.133" spread="131.4255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VIS410 Plasma Concentration ( AUC 0-infinity)</title>
        <description>VIS410 area under the plasma concentration time curve in serum. AUC 0-infinity is from the time of dosing extrapolated to infinity.</description>
        <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
        <population>The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
        </group_list>
        <measure>
          <title>VIS410 Plasma Concentration ( AUC 0-infinity)</title>
          <description>VIS410 area under the plasma concentration time curve in serum. AUC 0-infinity is from the time of dosing extrapolated to infinity.</description>
          <population>The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated</population>
          <units>day*mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8598.909" spread="38.3172"/>
                    <measurement group_id="O2" value="5371.988" spread="30.0631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VIS410 Plasma Concentration (AUC 0-last)</title>
        <description>VIS410 area under the plasma concentration time curve in serum. AUC 0-last is the area under the plasma concentration time curve from time 0 to the last measurable concentration.</description>
        <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
        <population>The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
        </group_list>
        <measure>
          <title>VIS410 Plasma Concentration (AUC 0-last)</title>
          <description>VIS410 area under the plasma concentration time curve in serum. AUC 0-last is the area under the plasma concentration time curve from time 0 to the last measurable concentration.</description>
          <population>The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated</population>
          <units>day*mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8441.244" spread="39.5852"/>
                    <measurement group_id="O2" value="5385.491" spread="31.2065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Half-life of VIS410 in Serum.</title>
        <description>Terminal elimination half-life of VIS410 in serum (t1/2) in serum.</description>
        <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
        <population>The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
        </group_list>
        <measure>
          <title>Half-life of VIS410 in Serum.</title>
          <description>Terminal elimination half-life of VIS410 in serum (t1/2) in serum.</description>
          <population>The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated</population>
          <units>day</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.941" spread="40.6241"/>
                    <measurement group_id="O2" value="10.119" spread="34.2559"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clearance (CL) of VIS410 in Serum.</title>
        <description>Summary of VIS410 total clearance (CL) in serum.</description>
        <time_frame>1, 3, 5, 7, 14, 28, 56, 100 days</time_frame>
        <population>The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance (CL) of VIS410 in Serum.</title>
          <description>Summary of VIS410 total clearance (CL) in serum.</description>
          <population>The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated.</population>
          <units>mL/day</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="465.175" spread="38.3172"/>
                    <measurement group_id="O2" value="372.302" spread="30.0631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.</title>
        <description>The difference between VIS410 and placebo treatment groups in viral AUC based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.</description>
        <time_frame>7 days</time_frame>
        <population>Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Summation of 4000 and 2000 mg VIS410 dose groups.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.</title>
          <description>The difference between VIS410 and placebo treatment groups in viral AUC based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.</description>
          <population>Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
          <units>d x log10 TCID50/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="90"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.726" lower_limit="0.15" upper_limit="14.44"/>
                    <measurement group_id="O2" value="3.570" lower_limit="0.14" upper_limit="13.37"/>
                    <measurement group_id="O3" value="3.660" lower_limit="0.14" upper_limit="14.44"/>
                    <measurement group_id="O4" value="4.782" lower_limit="0.28" upper_limit="16.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>A t-test was used to assess the difference between the VIS410 total and placebo treatment groups from nasopharyngeal swabs based on the TCID50.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.083</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Viral Load by TCID50</title>
        <description>The difference between VIS410 and placebo treatment groups in peak viral load based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.</description>
        <time_frame>7 days</time_frame>
        <population>Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Summation of 4000 and 2000 mg VIS410 dose groups.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Viral Load by TCID50</title>
          <description>The difference between VIS410 and placebo treatment groups in peak viral load based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.</description>
          <population>Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
          <units>log10 TCID50/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="90"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.125" lower_limit="0.38" upper_limit="5.75"/>
                    <measurement group_id="O2" value="2.50" lower_limit="0.38" upper_limit="4.75"/>
                    <measurement group_id="O3" value="2.625" lower_limit="0.38" upper_limit="5.75"/>
                    <measurement group_id="O4" value="3.375" lower_limit="0.38" upper_limit="6.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.169</p_value>
            <p_value_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.</title>
        <description>The number of days for the median time to resolution of peak viral load from end of infusion by nasopharyngeal swabs collected from the first 50 participants and tested by half maximal tissue culture infective dose (TCID50)</description>
        <time_frame>7 days</time_frame>
        <population>Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS649 Total</title>
            <description>Summation of 4000 and 2000 mg VIS410 dose groups.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.</title>
          <description>The number of days for the median time to resolution of peak viral load from end of infusion by nasopharyngeal swabs collected from the first 50 participants and tested by half maximal tissue culture infective dose (TCID50)</description>
          <population>Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="90"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.81" upper_limit="2.90"/>
                    <measurement group_id="O2" value="1.9" lower_limit="1.83" upper_limit="2.87"/>
                    <measurement group_id="O3" value="1.9" lower_limit="1.84" upper_limit="2.10"/>
                    <measurement group_id="O4" value="3.6" lower_limit="1.83" upper_limit="3.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Kaplan-Meier methods were used to calculate the median time. All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Descriptive Statistics. Statistical comparisons were performed using log rank test.</non_inferiority_desc>
            <p_value>0.028</p_value>
            <p_value_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Log Rank</method>
            <other_analysis_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level, unless specifically stated otherwise. All null hypotheses were defined as no treatment difference. All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary of Anti-VIS410 Antibody (ADA) Titers.</title>
        <description>Count of subjects testing positive for anti-VIS410 antibodies on days 1, 14, 56 and 100. A positive result includes samples confirmed positive and above titer cut point factor (and titer ≥ 1). Negative results include screened or confirmed negative or confirmed positive but below titer cut point factor (titer &lt; 1). For participants receiving placebo, only samples from two participants were tested at Days 14 and 56.</description>
        <time_frame>100 days</time_frame>
        <population>Safety Population The safety population included all ITT subjects who received IV study drug. The safety population summaries were based on the actual treatment received. Not all participants had samples for all timepoints. For participants receiving placebo, all participants were tested on Day 1 and Day 100; only samples from two participants were tested at Days 14 and 56.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous fixed dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous fixed dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>All participants receiving VIS410</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Anti-VIS410 Antibody (ADA) Titers.</title>
          <description>Count of subjects testing positive for anti-VIS410 antibodies on days 1, 14, 56 and 100. A positive result includes samples confirmed positive and above titer cut point factor (and titer ≥ 1). Negative results include screened or confirmed negative or confirmed positive but below titer cut point factor (titer &lt; 1). For participants receiving placebo, only samples from two participants were tested at Days 14 and 56.</description>
          <population>Safety Population The safety population included all ITT subjects who received IV study drug. The safety population summaries were based on the actual treatment received. Not all participants had samples for all timepoints. For participants receiving placebo, all participants were tested on Day 1 and Day 100; only samples from two participants were tested at Days 14 and 56.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="98"/>
                <count group_id="O4" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit day 1 anti-VIS410 antibody titer</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ADA Titer ≤ 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="88"/>
                    <measurement group_id="O4" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 1 to 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 4 to 16</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 16 to 64</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 64</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 anti-VIS410 antibody titer</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ADA Titer ≤ 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="89"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 1 to 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 4 to 16</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 16 to 64</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 64</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56 anti-VIS410 antibody titer</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="97"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ADA Titer ≤ 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 1 to 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 4 to 16</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 16 to 64</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 64</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 100 anti-VIS410 antibody titer</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ADA Titer ≤ 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="58"/>
                    <measurement group_id="O4" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 1 to 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 4 to 16</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 16 to 64</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADA Titer &gt; 64</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410</title>
        <description>The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. Data below show the time to symptom resolution for Total Symptom Score.</description>
        <time_frame>10 days</time_frame>
        <population>Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>Single intravenous dose of 4000 mg VIS410</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>Single intravenous dose of 2000 mg VIS410</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Summation of the 4000 and 2000 mg dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single dose intravenous saline solution</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410</title>
          <description>The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. Data below show the time to symptom resolution for Total Symptom Score.</description>
          <population>Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="90"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" lower_limit="1.4" upper_limit="4.1"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                    <measurement group_id="O3" value="2.1" lower_limit="1.0" upper_limit="3.8"/>
                    <measurement group_id="O4" value="2.6" lower_limit="1.3" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All null hypotheses were defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Descriptive Statistics. All statistical comparisons were performed at the 0.05 significance level.</non_inferiority_desc>
            <p_value>0.173</p_value>
            <p_value_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</p_value_desc>
            <method>Log Rank</method>
            <method_desc>Kaplan-Meier methods were used to calculate the median time, 25th percentile and 75th percentile.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored continuously from signing of informed consent until the last study related activity (100 days).</time_frame>
      <desc>New or worsening symptoms of influenza, including cough, sore throat, nasal congestion, fatigue, headache, myalgia or low-grade fever were in general, considered a component of the presenting illness, and were not reported as AEs unless they resulted in an SAE</desc>
      <group_list>
        <group group_id="E1">
          <title>VIS410 High Dose</title>
          <description>Single intravenous fixed dose of 4000 mg VIS410</description>
        </group>
        <group group_id="E2">
          <title>VIS410 Low Dose</title>
          <description>Single intravenous fixed dose of 2000 mg VIS410</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Single intravenous saline solution</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.1)</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="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="49"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E3" events="2" subjects_affected="2" 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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Visterra</organization>
      <phone>617-498-1070</phone>
      <email>clinicaltrials@visterrainc.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/NCT02989194
org study id: VIS410-202
nct id: NCT02989194
lead sponsor: 
collaborator: 
has dmc: Yes
This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the
      safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with
      uncomplicated influenza.
Subjects will be admitted to an infusion unit for drug administration and observation
      following infusion. The study is designed to compare an infusion of a single high or low IV
      dose of VIS410 against placebo. Subjects will be followed for 100 (±7 days).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection
time frame: 100 days
description: The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.
measure: Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest
time frame: 100 days
description: Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.
measure: Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410
time frame: 10 days
description: The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group. The data below show the percent change in mean total symptom scores over time by treatment arm.
measure: Hospitalization for Influenza-related Complications
time frame: 100 days
description: Number of participants requiring hospitalization for influenza-related complications
measure: Duration of Hospitalization for Complications of Influenza
time frame: 100 days
description: Duration of hospitalization for participants with at least 1 complication of influenza. There were no participants hospitalized for complications of influenza.
measure: Count of Participants With Complications of Influenza
time frame: 100 days
description: Count of participants with at least 1 complication of influenza
measure: Influenza A Relapse/Reinfection
time frame: 100 days
description: Number of participants with influenza A relapse/reinfection
measure: VIS410 Maximum Plasma Concentration
time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
description: The maximum observed concentration of VIS410 in serum (Cmax).
measure: Pharmacokinetics of VIS410 Concentration in Serum
time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
description: Time corresponding to the maximum serum concentration of VIS410.
measure: VIS410 Plasma Concentration ( AUC 0-infinity)
time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
description: VIS410 area under the plasma concentration time curve in serum. AUC 0-infinity is from the time of dosing extrapolated to infinity.
measure: VIS410 Plasma Concentration (AUC 0-last)
time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
description: VIS410 area under the plasma concentration time curve in serum. AUC 0-last is the area under the plasma concentration time curve from time 0 to the last measurable concentration.
measure: Half-life of VIS410 in Serum.
time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
description: Terminal elimination half-life of VIS410 in serum (t1/2) in serum.
measure: Clearance (CL) of VIS410 in Serum.
time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
description: Summary of VIS410 total clearance (CL) in serum.
measure: Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.
time frame: 7 days
description: The difference between VIS410 and placebo treatment groups in viral AUC based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.
measure: Peak Viral Load by TCID50
time frame: 7 days
description: The difference between VIS410 and placebo treatment groups in peak viral load based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.
measure: Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.
time frame: 7 days
description: The number of days for the median time to resolution of peak viral load from end of infusion by nasopharyngeal swabs collected from the first 50 participants and tested by half maximal tissue culture infective dose (TCID50)
measure: Summary of Anti-VIS410 Antibody (ADA) Titers.
time frame: 100 days
description: Count of subjects testing positive for anti-VIS410 antibodies on days 1, 14, 56 and 100. A positive result includes samples confirmed positive and above titer cut point factor (and titer ≥ 1). Negative results include screened or confirmed negative or confirmed positive but below titer cut point factor (titer < 1). For participants receiving placebo, only samples from two participants were tested at Days 14 and 56.
measure: Duration of Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410
time frame: 10 days
description: The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. Data below show the time to symptom resolution for Total Symptom Score.
arm group label: VIS410 low dose
arm group type: Experimental
description: Single intravenous fixed low dose of VIS410
arm group label: VIS410 high dose
arm group type: Experimental
description: Single intravenous fixed high dose of VIS410
arm group label: Placebo
arm group type: Placebo Comparator
description: Single intravenous placebo infusion
intervention type: Drug
intervention name: VIS410 low dose
description: Single intravenous fixed low dose of VIS410
arm group label: VIS410 low dose
intervention type: Drug
intervention name: VIS410 high dose
description: Single intravenous fixed high dose of VIS410
arm group label: VIS410 high dose
intervention type: Drug
intervention name: Placebo
description: Single intravenous infusion of placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Clinical Development
role: Study Director
affiliation: Visterra, Inc.
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country: Bulgaria
country: Estonia
country: Latvia
country: Serbia
country: South Africa
country: Ukraine
country: United States
citation: Hershberger E, Sloan S, Narayan K, Hay CA, Smith P, Engler F, Jeeninga R, Smits S, Trevejo J, Shriver Z, Oldach D. Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study. EBioMedicine. 2019 Feb;40:574-582. doi: 10.1016/j.ebiom.2018.12.051. Epub 2019 Jan 9.
PMID: 30638863
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No
ipd description: No plans to share IPD
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 