<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/NCT02979431</url>
  </required_header>
  <id_info>
    <org_study_id>ALX0171-C201</org_study_id>
    <secondary_id>2016-001651-49</secondary_id>
    <nct_id>NCT02979431</nct_id>
  </id_info>
  <brief_title>Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection</brief_title>
  <acronym>Respire</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study of ALX-0171 in Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ablynx, a Sanofi company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ablynx, a Sanofi company</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to evaluate the anti-viral effect and safety of different doses of&#xD;
      inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory&#xD;
      Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity,&#xD;
      pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different&#xD;
      doses of inhaled ALX-0171.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a Phase 2b, randomized, double-blind, placebo-controlled, international, multicenter&#xD;
      dose-ranging study in infants and toddlers hospitalized for RSV LRTI. The study evaluated 3&#xD;
      dose levels of ALX-0171 in a sequential part (safety Cohorts 1-3) followed by a parallel part&#xD;
      (Cohort 4).&#xD;
&#xD;
      An Independent Data Monitoring Committee (IDMC) was assigned to review study data and provide&#xD;
      recommendations on proceeding to the next safety cohort and on which dose levels could be&#xD;
      taken forward in the parallel part.&#xD;
&#xD;
      Three dose levels of ALX-0171 were evaluated:&#xD;
&#xD;
        -  Dose 1: target dose of 3.0 mg/kg&#xD;
&#xD;
        -  Dose 2: target dose of 6.0 mg/kg&#xD;
&#xD;
        -  Dose 3: target dose of 9.0 mg/kg&#xD;
&#xD;
      The study drug was administered by inhalation once daily for 3 consecutive days along with&#xD;
      standard of care treatment, which was determined by the Investigator (or his/her designee)&#xD;
      according to institutional practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2017</start_date>
  <completion_date type="Actual">May 25, 2018</completion_date>
  <primary_completion_date type="Actual">May 25, 2018</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>Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis)</measure>
    <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
    <description>The primary endpoint for this trial was the time needed for the viral load to drop below the quantification limit (time-to-BQL) of the plaque assay in nasal mid-turbinate swab specimens. Time-to-BQL was defined as the time from the first study drug administration to the first occurrence of a value below the quantification limit (BQL), provided the next measured value was also below the limit of quantification. The time to BQL for subjects with missing data and/or who did not reach BQL during the trial were censored at the last non-missing viral load assessment. The primary endpoint was analysed using logrank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05. The comparisons were performed in the following order: ALX-0171 9 mg/kg vs Placebo, followed by ALX-0171 6mg/kg vs Placebo, ALX-0171 3mg/kg vs Placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose)</measure>
    <time_frame>from Baseline untill Day 2 (5 hours post-dose)</time_frame>
    <description>A formal comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to and including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used. The model was fitted using an unstructured variance-covariance matrix.&#xD;
The individual pair-wise comparisons were reported (comparison in least square [LS] means for 9.0 mg/kg versus placebo; 6.0mg/kg versus placebo; 3.0 mg/kg versus placebo).&#xD;
Evolution over time in Global Severity Score. The maximum total score is 20 (minimum:0 to manimum:20); higher score indicates more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-Clinical Response</measure>
    <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
    <description>The time-to-clinical response was defined as the time between the first study drug administration and the time of achieving adequate oxygen saturation (defined as SpO2 &gt; 92% over a period of at least 4 hours) and adequate oral feeding (which is sufficient to maintain sufficient hydration, in the judgment of the Investigator).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-BQL (RT-qPCR)</measure>
    <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
    <description>As secondary endpoint, the time-to-BQL using RT-qPCR was summarized using Kaplan Meier (KM) estimates. No p-values were calculated. For RSV load by RT-qPCR, the lower limit of quantification (LLOQ) was 2.4 log10 copies/mL.&#xD;
The upper limit confidence interval (CI) could not be calculated; Values of the 25 percentile are reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-undetectable Viral Load (Plaque Assay Analysis)</measure>
    <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
    <description>The time-to-undetectability (hours), defined as the time from the first study drug administration to the first occurrence of viral titer below the lower limit of quantification (LLOQ), and target not detected provided the next measured value was also below the quantification limit and undetected, were summarized using KM estimates, based on the plaque assay. The time-to-event for subjects with missing data and/or subjects who did not reach undetectability during the trial were censored at the last non-missing viral load assessment. For RSV load by plaque assay the LLOQ was 1.7 log10 pfu/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Load Changes From Baseline (Plaque Assay Analysis)</measure>
    <time_frame>From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)</time_frame>
    <description>Change from Baseline in RSV Load measured by Plaque Assay (RSV Infected Population)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Load Changes From Baseline (RT-qPCR Analysis)</measure>
    <time_frame>From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)</time_frame>
    <description>Change from Baseline in RSV Load measured by RT-qPCR (RSV Infected Population)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis)</measure>
    <time_frame>From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)</time_frame>
    <description>The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t&lt;x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis)</measure>
    <time_frame>From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)</time_frame>
    <description>The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t&lt;x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies</measure>
    <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
    <description>The number of subjects with treatment-emergent (TE) anti-drug antibodies (ADA; TE ADA) based on ADA assay by treatment group for the Safety Population. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.&#xD;
Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity; Number of Subjects With Treatment-emergent Neutralizing Antibodies</measure>
    <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
    <description>Number of subjects with treatment-emergent neutralizing antibodies (TE NAb) as detected with the competitive ligand binding NAb assay. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.&#xD;
Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Respiratory Syncytial Virus Lower Respiratory Tract Infection</condition>
  <arm_group>
    <arm_group_label>ALX-0171 3.0 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALX-0171 6.0 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALX-0171 Dose 9.0mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Inhalation of Placebo once daily for 3 consecutive days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALX-0171 3.0 mg/kg</intervention_name>
    <arm_group_label>ALX-0171 3.0 mg/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALX-0171 6.0 mg/kg</intervention_name>
    <arm_group_label>ALX-0171 6.0 mg/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALX-0171 9.0 mg/kg</intervention_name>
    <arm_group_label>ALX-0171 Dose 9.0mg/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Matching Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female infant or young child aged 28 days to &lt; 2 years with gestational age ≥&#xD;
             33 weeks at screening.&#xD;
&#xD;
          2. Subject weighed between ≥ 3.0 kg and &lt; 15.0 kg at screening.&#xD;
&#xD;
          3. Subject is otherwise healthy but was hospitalized for and clinically diagnosed with&#xD;
             RSV LRTI (bronchiolitis or broncho-pneumonia), i.e., showing typical clinical signs&#xD;
             and symptoms such as tachypnea, wheezing, cough, crackles, use of accessory muscles&#xD;
             and/or nasal flaring.&#xD;
&#xD;
          4. Subject had a positive RSV diagnostic test at screening.&#xD;
&#xD;
          5. Subject was expected to have to stay in the hospital for at least 24 hours (according&#xD;
             to the Investigator's judgment at screening).&#xD;
&#xD;
          6. Symptoms were likely related to RSV infection (i.e., the symptoms present needed to be&#xD;
             probably linked to the current RSV infection according to Investigator's judgment) had&#xD;
             appeared within 4 days of screening and were not yet improving at screening and&#xD;
             randomization.&#xD;
&#xD;
          7. Subject fulfilled at least 2 of the following RSV disease severity criteria at&#xD;
             screening and randomization:&#xD;
&#xD;
               -  Inadequate oral feeding that required feeding support (i.e., nasogastric tube or&#xD;
                  intravenous [i.v.] line)&#xD;
&#xD;
               -  Inadequate oxygen saturation defined as:&#xD;
&#xD;
                    -  Oxygen saturation (peripheral capillary oxygen saturation [SpO2]) ≤ 92% on&#xD;
                       room air or&#xD;
&#xD;
                    -  Requiring oxygen supplementation to maintain oxygen saturation &gt; 90% with&#xD;
                       documented pre-supplementation value ≤ 92%&#xD;
&#xD;
               -  Signs of respiratory distress defined as:&#xD;
&#xD;
                    -  Respiratory rate ≥ 50 per minute in infants up to 12 months of age, and ≥ 40&#xD;
                       per minute in children above 12 months and/or&#xD;
&#xD;
                    -  Moderate or marked respiratory muscle retractions&#xD;
&#xD;
          8. Normal psychomotor development.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject was known to have significant comorbidities including:&#xD;
&#xD;
               -  Genetic disorders (e.g., trisomy 21, cystic fibrosis),&#xD;
&#xD;
               -  Hemodynamically significant congenital heart disease (e.g., needing corrective&#xD;
                  therapy or inotropic support),&#xD;
&#xD;
               -  Bronchopulmonary dysplasia,&#xD;
&#xD;
               -  Any hereditary or acquired metabolic (bone) diseases,&#xD;
&#xD;
               -  Hematologic or other malignancy.&#xD;
&#xD;
          2. Subject was known to be human immunodeficiency virus (HIV)-positive. If the subject&#xD;
             was &lt; 6 months of age, a known HIV-positivity of the mother was also exclusionary.&#xD;
&#xD;
          3. Subject was known to be immunocompromised.&#xD;
&#xD;
          4. Subject had or was suspected to have an active, clinically relevant concurrent&#xD;
             infection (e.g., bacterial pneumonia, urinary tract infection). Concurrent acute&#xD;
             otitis media was not exclusionary.&#xD;
&#xD;
          5. Subject had significant oral and/or maxillofacial malformations that would prevent&#xD;
             proper positioning of the face mask.&#xD;
&#xD;
          6. Subject received invasive mechanical ventilation or non-invasive respiratory support&#xD;
             (i.e., continuous or bilevel positive airway pressure) in the 4 weeks prior to&#xD;
             screening.&#xD;
&#xD;
          7. During the admission, the subject was initially hospitalized in an intensive care unit&#xD;
             (ICU) setting and/or had received invasive mechanical ventilation or non-invasive&#xD;
             respiratory support (i.e., continuous or bilevel positive airway pressure).&#xD;
&#xD;
          8. Subject was critically ill and/or was expected to require invasive mechanical&#xD;
             ventilation, non invasive respiratory support (i.e., continuous or bilevel positive&#xD;
             airway pressure), or High Flow oxygen therapy (HFOT) at levels not enabling&#xD;
             nebulization therapy according to the Investigator's judgment. High Flow oxygen, with&#xD;
             a maximum flow of 2 L/kg/min, was permitted under the following conditions:&#xD;
&#xD;
               -  used as Standard of Care outside ICU setting&#xD;
&#xD;
               -  could be removed for study drug administration (Note: oxygen flow at 2 L/min&#xD;
                  could be provided)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Days</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ablynx Clinical Department</last_name>
    <role>Study Director</role>
    <affiliation>Ablynx, a Sanofi company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigator site 2</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Roeselare</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Kozloduy</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Ruse</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Stara Zagora</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Valdivia</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Floridablanca</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 1</name>
      <address>
        <city>Medellín</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site 2</name>
      <address>
        <city>Medellín</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Cakovec</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Osijek</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Slavonski Brod</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Varaždin</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site 1</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site 2</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site 3</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site 4</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Hradec Králové</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Tartu</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Sankt Augustin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Wuppertal</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Balassagyarmat</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site 1</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 2</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 3</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 4</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Szekesfehervar</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Veszprém</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Beer sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Petah tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Daugavpils</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>George Town</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Seremban</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Sibu</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Alabang</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 1</name>
      <address>
        <city>Quezon City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 2</name>
      <address>
        <city>Quezon City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Trzebnica</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Banská Bystrica</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Košice</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Poprad</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 1</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 2</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 3</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>El Palmar</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site 1</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 2</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site 1</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site 2</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Chiang Mai</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator site</name>
      <address>
        <city>Hat Yai</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator Site</name>
      <address>
        <city>Khon Kaen</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Latvia</country>
    <country>Malaysia</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Thailand</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
    <country>Lithuania</country>
    <country>South Africa</country>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>May 22, 2019</results_first_submitted>
  <results_first_submitted_qc>September 25, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 18, 2019</results_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RSV, Lower Respiratory Tract Infection, pediattric patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gontivimab</mesh_term>
  </intervention_browse>
  <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>October 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02979431/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>August 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02979431/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 301 subjects were screened.180 subjects were randomized to receive ALX-0171 3.0 mg/kg, ALX-0171 6.0 mg/kg, ALX-0171 9.0 mg/kg or placebo, yielding an overall allocation ratio of 3:1 active to placebo.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Inhalation of Placebo once daily for 3 consecutive days</description>
        </group>
        <group group_id="P2">
          <title>ALX-0171 3.0 mg/kg</title>
          <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
        </group>
        <group group_id="P3">
          <title>ALX-0171 6.0 mg/kg</title>
          <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
        </group>
        <group group_id="P4">
          <title>ALX-0171 9.0mg/kg</title>
          <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="46"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Included in the mITT Population</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="43"/>
                <participants group_id="P4" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Included in the Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="44">Includes a subject that was randomized to placebo but received a dose of ALX-0171 6.0 mg/kg</participants>
                <participants group_id="P4" count="46">Includes a subject that was randomized to placebo but received a dose of ALX-0171 9.0 mg/kg</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="43"/>
                <participants group_id="P4" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Parent/guardian withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but received no study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject left country after Day14</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Inhalation of Placebo once daily for 3 consecutive days</description>
        </group>
        <group group_id="B2">
          <title>ALX-0171 3.0 mg/kg</title>
          <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
        </group>
        <group group_id="B3">
          <title>ALX-0171 6.0 mg/kg</title>
          <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
        </group>
        <group group_id="B4">
          <title>ALX-0171 9.0mg/kg</title>
          <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
        </group>
        <group group_id="B5">
          <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="42"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="43"/>
            <count group_id="B4" value="45"/>
            <count group_id="B5" value="175"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="45"/>
                    <measurement group_id="B5" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 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 group_id="B5" value="0"/>
                  </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 group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>The age reported is the age at the time of informed consent signing.</description>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.964" spread="6.0668"/>
                    <measurement group_id="B2" value="6.933" spread="5.8827"/>
                    <measurement group_id="B3" value="6.657" spread="6.2605"/>
                    <measurement group_id="B4" value="7.022" spread="5.6884"/>
                    <measurement group_id="B5" value="6.896" spread="5.9234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age categories</title>
              <category_list>
                <category>
                  <title>&lt; 6 months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 6 months and &lt; 12 months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 12 months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <description>Age, Customized; Gestational Age</description>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>Weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Gestational Age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.5" spread="1.78"/>
                    <measurement group_id="B2" value="38.6" spread="1.99"/>
                    <measurement group_id="B3" value="38.6" spread="1.62"/>
                    <measurement group_id="B4" value="38.3" spread="1.54"/>
                    <measurement group_id="B5" value="38.5" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="157"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <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="3"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colombia</title>
              <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="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Croatia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <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="2"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latvia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaysia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Philippines</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thailand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of days between symtpom onset and the first dose of study drug</title>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.16" spread="1.207"/>
                    <measurement group_id="B2" value="3.34" spread="1.144"/>
                    <measurement group_id="B3" value="3.23" spread="0.845"/>
                    <measurement group_id="B4" value="3.25" spread="1.149"/>
                    <measurement group_id="B5" value="3.25" spread="1.088"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Global Severity Score (GSS)</title>
          <description>The GSS is a composite score based on the ReSVinet Scale (Justicia-Grande et al., 2016) that allowed for objective categorization of infants with respiratory infections based on seven different items (i.e., feeding intolerance, medical intervention, respiratory difficulty, respiratory frequency, apnea, general condition, and fever). The sum of the sub-item scores provides the GSS total score (range: 0-20). Higher score indicates more severe disease.</description>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.1" spread="2.44"/>
                    <measurement group_id="B2" value="9.2" spread="2.00"/>
                    <measurement group_id="B3" value="9.3" spread="2.09"/>
                    <measurement group_id="B4" value="9.4" spread="2.41"/>
                    <measurement group_id="B5" value="9.2" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Respiratory Distress Instrument (RDAI)</title>
          <description>The RDAI instrument is a 17-point scoring system based on wheezing and retraction. The sum of the subscores provides the RDAI total score, with total range 0 to 17. Higher scores indicating more severe disease.</description>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.5" spread="3.74"/>
                    <measurement group_id="B2" value="8.41" spread="4.07"/>
                    <measurement group_id="B3" value="8.74" spread="3.19"/>
                    <measurement group_id="B4" value="8.11" spread="3.80"/>
                    <measurement group_id="B5" value="8.44" spread="3.693"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimetres</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.84" spread="9.997"/>
                    <measurement group_id="B2" value="65.71" spread="10.210"/>
                    <measurement group_id="B3" value="65.25" spread="10.190"/>
                    <measurement group_id="B4" value="66.55" spread="9.580"/>
                    <measurement group_id="B5" value="65.85" spread="9.915"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.065" spread="2.4193"/>
                    <measurement group_id="B2" value="7.188" spread="2.2278"/>
                    <measurement group_id="B3" value="6.988" spread="2.4084"/>
                    <measurement group_id="B4" value="7.020" spread="2.2474"/>
                    <measurement group_id="B5" value="7.066" spread="2.3059"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>≥ 3.0 kg and &lt; 4.0 kg</title>
                  <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="2"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 4.0 kg and &lt; 5.0 kg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 5.0 kg and &lt; 7.0 kg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 7.0 kg and &lt; 10.0 kg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 10.0 kg and &lt; 12.0 kg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 12.0 kg and &lt; 15.0 kg</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis)</title>
        <description>The primary endpoint for this trial was the time needed for the viral load to drop below the quantification limit (time-to-BQL) of the plaque assay in nasal mid-turbinate swab specimens. Time-to-BQL was defined as the time from the first study drug administration to the first occurrence of a value below the quantification limit (BQL), provided the next measured value was also below the limit of quantification. The time to BQL for subjects with missing data and/or who did not reach BQL during the trial were censored at the last non-missing viral load assessment. The primary endpoint was analysed using logrank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05. The comparisons were performed in the following order: ALX-0171 9 mg/kg vs Placebo, followed by ALX-0171 6mg/kg vs Placebo, ALX-0171 3mg/kg vs Placebo.</description>
        <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
        <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis)</title>
          <description>The primary endpoint for this trial was the time needed for the viral load to drop below the quantification limit (time-to-BQL) of the plaque assay in nasal mid-turbinate swab specimens. Time-to-BQL was defined as the time from the first study drug administration to the first occurrence of a value below the quantification limit (BQL), provided the next measured value was also below the limit of quantification. The time to BQL for subjects with missing data and/or who did not reach BQL during the trial were censored at the last non-missing viral load assessment. The primary endpoint was analysed using logrank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05. The comparisons were performed in the following order: ALX-0171 9 mg/kg vs Placebo, followed by ALX-0171 6mg/kg vs Placebo, ALX-0171 3mg/kg vs Placebo.</description>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>hours</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="42"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.1" lower_limit="29.33" upper_limit="94.42"/>
                    <measurement group_id="O2" value="14.2" lower_limit="5.17" upper_limit="26.28"/>
                    <measurement group_id="O3" value="5.1" lower_limit="4.78" upper_limit="24.72"/>
                    <measurement group_id="O4" value="5.1" lower_limit="4.97" upper_limit="5.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Log Rank</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.001</p_value>
            <method>Log Rank</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose)</title>
        <description>A formal comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to and including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used. The model was fitted using an unstructured variance-covariance matrix.&#xD;
The individual pair-wise comparisons were reported (comparison in least square [LS] means for 9.0 mg/kg versus placebo; 6.0mg/kg versus placebo; 3.0 mg/kg versus placebo).&#xD;
Evolution over time in Global Severity Score. The maximum total score is 20 (minimum:0 to manimum:20); higher score indicates more severe disease.</description>
        <time_frame>from Baseline untill Day 2 (5 hours post-dose)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose)</title>
          <description>A formal comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to and including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used. The model was fitted using an unstructured variance-covariance matrix.&#xD;
The individual pair-wise comparisons were reported (comparison in least square [LS] means for 9.0 mg/kg versus placebo; 6.0mg/kg versus placebo; 3.0 mg/kg versus placebo).&#xD;
Evolution over time in Global Severity Score. The maximum total score is 20 (minimum:0 to manimum:20); higher score indicates more severe disease.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6392" spread="0.4160"/>
                    <measurement group_id="O2" value="-3.8548" spread="0.4103"/>
                    <measurement group_id="O3" value="-4.1296" spread="0.4129"/>
                    <measurement group_id="O4" value="-4.2844" spread="0.4099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>A comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to + including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used.The model was fitted using an unstructured variance-covariance matrix.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.271</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.6452</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.5843</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.404</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Difference in LS means</param_type>
            <param_value>-0.4904</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.5862</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.713</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Difference in LS means</param_type>
            <param_value>-0.2156</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.5842</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time-to-Clinical Response</title>
        <description>The time-to-clinical response was defined as the time between the first study drug administration and the time of achieving adequate oxygen saturation (defined as SpO2 &gt; 92% over a period of at least 4 hours) and adequate oral feeding (which is sufficient to maintain sufficient hydration, in the judgment of the Investigator).</description>
        <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
        <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Time-to-Clinical Response</title>
          <description>The time-to-clinical response was defined as the time between the first study drug administration and the time of achieving adequate oxygen saturation (defined as SpO2 &gt; 92% over a period of at least 4 hours) and adequate oral feeding (which is sufficient to maintain sufficient hydration, in the judgment of the Investigator).</description>
          <population>modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).</population>
          <units>hours</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="42"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time-to-Clinical Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.9" lower_limit="29.17" upper_limit="64.08"/>
                    <measurement group_id="O2" value="44.1" lower_limit="28.33" upper_limit="51.20"/>
                    <measurement group_id="O3" value="27.9" lower_limit="21.08" upper_limit="43.68"/>
                    <measurement group_id="O4" value="46.3" lower_limit="38.00" upper_limit="50.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-to-adequate oral feeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.7" lower_limit="22.50" upper_limit="47.58"/>
                    <measurement group_id="O2" value="44.0" lower_limit="25.92" upper_limit="52.00"/>
                    <measurement group_id="O3" value="17.6" lower_limit="6.50" upper_limit="25.85"/>
                    <measurement group_id="O4" value="23.8" lower_limit="17.17" upper_limit="38.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-to-adequate oxygen saturation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.4" lower_limit="28.70" upper_limit="71.78"/>
                    <measurement group_id="O2" value="38.5" lower_limit="24.75" upper_limit="61.93"/>
                    <measurement group_id="O3" value="29.5" lower_limit="20.75" upper_limit="47.43"/>
                    <measurement group_id="O4" value="46.5" lower_limit="42.15" upper_limit="48.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time-to-BQL (RT-qPCR)</title>
        <description>As secondary endpoint, the time-to-BQL using RT-qPCR was summarized using Kaplan Meier (KM) estimates. No p-values were calculated. For RSV load by RT-qPCR, the lower limit of quantification (LLOQ) was 2.4 log10 copies/mL.&#xD;
The upper limit confidence interval (CI) could not be calculated; Values of the 25 percentile are reported here.</description>
        <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
        <population>The modified ITT (mITT) population consisted of all randomized subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as randomized (i.e., using the treatment to which the subject was randomized).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Time-to-BQL (RT-qPCR)</title>
          <description>As secondary endpoint, the time-to-BQL using RT-qPCR was summarized using Kaplan Meier (KM) estimates. No p-values were calculated. For RSV load by RT-qPCR, the lower limit of quantification (LLOQ) was 2.4 log10 copies/mL.&#xD;
The upper limit confidence interval (CI) could not be calculated; Values of the 25 percentile are reported here.</description>
          <population>The modified ITT (mITT) population consisted of all randomized subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as randomized (i.e., using the treatment to which the subject was randomized).</population>
          <units>hours</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="42"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7" lower_limit="5.0" upper_limit="49.92"/>
                    <measurement group_id="O2" value="26.8" lower_limit="5.17" upper_limit="44.62"/>
                    <measurement group_id="O3" value="28.9" lower_limit="18.25" upper_limit="49.25"/>
                    <measurement group_id="O4" value="6.3" lower_limit="4.97" upper_limit="25.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time-to-undetectable Viral Load (Plaque Assay Analysis)</title>
        <description>The time-to-undetectability (hours), defined as the time from the first study drug administration to the first occurrence of viral titer below the lower limit of quantification (LLOQ), and target not detected provided the next measured value was also below the quantification limit and undetected, were summarized using KM estimates, based on the plaque assay. The time-to-event for subjects with missing data and/or subjects who did not reach undetectability during the trial were censored at the last non-missing viral load assessment. For RSV load by plaque assay the LLOQ was 1.7 log10 pfu/mL.</description>
        <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
        <population>RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Time-to-undetectable Viral Load (Plaque Assay Analysis)</title>
          <description>The time-to-undetectability (hours), defined as the time from the first study drug administration to the first occurrence of viral titer below the lower limit of quantification (LLOQ), and target not detected provided the next measured value was also below the quantification limit and undetected, were summarized using KM estimates, based on the plaque assay. The time-to-event for subjects with missing data and/or subjects who did not reach undetectability during the trial were censored at the last non-missing viral load assessment. For RSV load by plaque assay the LLOQ was 1.7 log10 pfu/mL.</description>
          <population>RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.</population>
          <units>hours</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="35"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.9" lower_limit="47.23" upper_limit="121.82"/>
                    <measurement group_id="O2" value="26.3" lower_limit="20.25" upper_limit="28.92"/>
                    <measurement group_id="O3" value="21.0" lower_limit="4.88" upper_limit="28.25"/>
                    <measurement group_id="O4" value="5.1" lower_limit="5.00" upper_limit="5.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Viral Load Changes From Baseline (Plaque Assay Analysis)</title>
        <description>Change from Baseline in RSV Load measured by Plaque Assay (RSV Infected Population)</description>
        <time_frame>From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)</time_frame>
        <population>RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Load Changes From Baseline (Plaque Assay Analysis)</title>
          <description>Change from Baseline in RSV Load measured by Plaque Assay (RSV Infected Population)</description>
          <population>RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.</population>
          <units>log10 pfu/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.494" spread="0.2396"/>
                    <measurement group_id="O2" value="3.312" spread="0.2165"/>
                    <measurement group_id="O3" value="3.135" spread="0.2430"/>
                    <measurement group_id="O4" value="2.385" spread="0.2526"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 5 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.270" spread="0.1607"/>
                    <measurement group_id="O2" value="-2.173" spread="0.2123"/>
                    <measurement group_id="O3" value="-2.189" spread="0.2676"/>
                    <measurement group_id="O4" value="-1.535" spread="0.2526"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3, 2 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.936" spread="0.2317"/>
                    <measurement group_id="O2" value="-2.396" spread="0.2234"/>
                    <measurement group_id="O3" value="-2.134" spread="0.2525"/>
                    <measurement group_id="O4" value="-1.516" spread="0.2558"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.368" spread="0.2946"/>
                    <measurement group_id="O2" value="-2.431" spread="0.2202"/>
                    <measurement group_id="O3" value="-2.279" spread="0.2576"/>
                    <measurement group_id="O4" value="-1.416" spread="0.2821"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Viral Load Changes From Baseline (RT-qPCR Analysis)</title>
        <description>Change from Baseline in RSV Load measured by RT-qPCR (RSV Infected Population)</description>
        <time_frame>From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)</time_frame>
        <population>RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Load Changes From Baseline (RT-qPCR Analysis)</title>
          <description>Change from Baseline in RSV Load measured by RT-qPCR (RSV Infected Population)</description>
          <population>RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.</population>
          <units>log10 copies/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.236" spread="0.2827"/>
                    <measurement group_id="O2" value="4.966" spread="0.2095"/>
                    <measurement group_id="O3" value="5.232" spread="0.1899"/>
                    <measurement group_id="O4" value="4.525" spread="0.2937"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 5 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.221" spread="0.1601"/>
                    <measurement group_id="O2" value="-0.544" spread="0.1286"/>
                    <measurement group_id="O3" value="-0.241" spread="0.2031"/>
                    <measurement group_id="O4" value="-0.449" spread="0.1883"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3, 2 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.156" spread="0.2454"/>
                    <measurement group_id="O2" value="-2.589" spread="0.2138"/>
                    <measurement group_id="O3" value="-2.310" spread="0.2797"/>
                    <measurement group_id="O4" value="-2.025" spread="0.2840"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.413" spread="0.3715"/>
                    <measurement group_id="O2" value="-3.665" spread="0.2203"/>
                    <measurement group_id="O3" value="-3.972" spread="0.2032"/>
                    <measurement group_id="O4" value="-3.033" spread="0.3252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis)</title>
        <description>The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t&lt;x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.</description>
        <time_frame>From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)</time_frame>
        <population>RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis)</title>
          <description>The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t&lt;x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.</description>
          <population>RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.</population>
          <units>log10 pfu/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.494" spread="0.2396"/>
                    <measurement group_id="O2" value="3.312" spread="0.2165"/>
                    <measurement group_id="O3" value="3.135" spread="0.2430"/>
                    <measurement group_id="O4" value="2.385" spread="0.2526"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.014" spread="0.1540"/>
                    <measurement group_id="O2" value="-1.924" spread="0.1659"/>
                    <measurement group_id="O3" value="-1.804" spread="0.2098"/>
                    <measurement group_id="O4" value="-1.330" spread="0.2434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.096" spread="0.2443"/>
                    <measurement group_id="O2" value="-2.295" spread="0.2116"/>
                    <measurement group_id="O3" value="-2.028" spread="0.2217"/>
                    <measurement group_id="O4" value="-1.419" spread="0.2488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis)</title>
        <description>The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t&lt;x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.</description>
        <time_frame>From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)</time_frame>
        <population>RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis)</title>
          <description>The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t&lt;x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.</description>
          <population>RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.</population>
          <units>log10 copies/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.236" spread="0.2827"/>
                    <measurement group_id="O2" value="4.966" spread="0.2095"/>
                    <measurement group_id="O3" value="5.232" spread="0.1899"/>
                    <measurement group_id="O4" value="4.525" spread="0.2937"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.933" spread="0.1421"/>
                    <measurement group_id="O2" value="-1.209" spread="0.1301"/>
                    <measurement group_id="O3" value="-1.113" spread="0.1932"/>
                    <measurement group_id="O4" value="-0.842" spread="0.1842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.684" spread="0.2263"/>
                    <measurement group_id="O2" value="-2.828" spread="0.2099"/>
                    <measurement group_id="O3" value="-2.756" spread="0.1831"/>
                    <measurement group_id="O4" value="-2.292" spread="0.2581"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies</title>
        <description>The number of subjects with treatment-emergent (TE) anti-drug antibodies (ADA; TE ADA) based on ADA assay by treatment group for the Safety Population. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.&#xD;
Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.</description>
        <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
        <population>The Safety Population consisted of all subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as treated (i.e., using the treatment that the subject actually received). Number of subjects with non-missing ADA results were: placebo:39; ALX-0171 3.0mg/kg:45; 6.0mg/kg:44; 9.0mg/kg:46.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies</title>
          <description>The number of subjects with treatment-emergent (TE) anti-drug antibodies (ADA; TE ADA) based on ADA assay by treatment group for the Safety Population. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.&#xD;
Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.</description>
          <population>The Safety Population consisted of all subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as treated (i.e., using the treatment that the subject actually received). Number of subjects with non-missing ADA results were: placebo:39; ALX-0171 3.0mg/kg:45; 6.0mg/kg:44; 9.0mg/kg:46.</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="39"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total TE ADA Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total TE ADA Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TE ADA Equivocal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TE ADA Inconclusive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity; Number of Subjects With Treatment-emergent Neutralizing Antibodies</title>
        <description>Number of subjects with treatment-emergent neutralizing antibodies (TE NAb) as detected with the competitive ligand binding NAb assay. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.&#xD;
Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.</description>
        <time_frame>Overall Study Period (i.e., approximately 28 days)</time_frame>
        <population>The Safety Population consisted of all subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as treated (i.e., using the treatment that the subject actually received).Number of subjects with non-missing NAb results were: placebo:39; ALX-0171 3.0mg/kg:45; 6.0mg/kg:44; 9.0mg/kg:46.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Inhalation of Placebo once daily for 3 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>ALX-0171 3.0 mg/kg</title>
            <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>ALX-0171 6.0 mg/kg</title>
            <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>ALX-0171 9.0mg/kg</title>
            <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity; Number of Subjects With Treatment-emergent Neutralizing Antibodies</title>
          <description>Number of subjects with treatment-emergent neutralizing antibodies (TE NAb) as detected with the competitive ligand binding NAb assay. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.&#xD;
Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.</description>
          <population>The Safety Population consisted of all subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as treated (i.e., using the treatment that the subject actually received).Number of subjects with non-missing NAb results were: placebo:39; ALX-0171 3.0mg/kg:45; 6.0mg/kg:44; 9.0mg/kg:46.</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="39"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-dose Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-dose Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-dose Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events (AEs) were reported from first study drug intake to the end of study visit (Day 28) or withdrawal visit.</time_frame>
      <desc>A treatment-emergent AE (TEAE) was defined as any AE starting or worsening in severity (for preexisting conditions) from the start of study drug administration, until completion of the subject's last visit.&#xD;
Adverse event data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Inhalation of Placebo once daily for 3 consecutive days</description>
        </group>
        <group group_id="E2">
          <title>ALX-0171 3.0 mg/kg</title>
          <description>Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days</description>
        </group>
        <group group_id="E3">
          <title>ALX-0171 6.0 mg/kg</title>
          <description>Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days</description>
        </group>
        <group group_id="E4">
          <title>ALX-0171 9.0mg/kg</title>
          <description>Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vessel puncture site phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pneumonococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA">Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (21.0)</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="17" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Conjuctivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinorrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </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>Publication of any results from this study will be according to the principles of the Declaration of Helsinki, and will require prior review and written agreement of the Sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Monitor</name_or_title>
      <organization>Ablynx NV</organization>
      <phone>+32 (0)9262 00 00</phone>
      <email>clinicaltrials@ablynx.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/NCT02979431
org study id: ALX0171-C201
secondary id: 2016-001651-49
nct id: NCT02979431
lead sponsor: 
has dmc: Yes
The primary objective is to evaluate the anti-viral effect and safety of different doses of
      inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory
      Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity,
      pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different
      doses of inhaled ALX-0171.
This was a Phase 2b, randomized, double-blind, placebo-controlled, international, multicenter
      dose-ranging study in infants and toddlers hospitalized for RSV LRTI. The study evaluated 3
      dose levels of ALX-0171 in a sequential part (safety Cohorts 1-3) followed by a parallel part
      (Cohort 4).

      An Independent Data Monitoring Committee (IDMC) was assigned to review study data and provide
      recommendations on proceeding to the next safety cohort and on which dose levels could be
      taken forward in the parallel part.

      Three dose levels of ALX-0171 were evaluated:

        -  Dose 1: target dose of 3.0 mg/kg

        -  Dose 2: target dose of 6.0 mg/kg

        -  Dose 3: target dose of 9.0 mg/kg

      The study drug was administered by inhalation once daily for 3 consecutive days along with
      standard of care treatment, which was determined by the Investigator (or his/her designee)
      according to institutional practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis)
time frame: Overall Study Period (i.e., approximately 28 days)
description: The primary endpoint for this trial was the time needed for the viral load to drop below the quantification limit (time-to-BQL) of the plaque assay in nasal mid-turbinate swab specimens. Time-to-BQL was defined as the time from the first study drug administration to the first occurrence of a value below the quantification limit (BQL), provided the next measured value was also below the limit of quantification. The time to BQL for subjects with missing data and/or who did not reach BQL during the trial were censored at the last non-missing viral load assessment. The primary endpoint was analysed using logrank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05. The comparisons were performed in the following order: ALX-0171 9 mg/kg vs Placebo, followed by ALX-0171 6mg/kg vs Placebo, ALX-0171 3mg/kg vs Placebo.
measure: Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose)
time frame: from Baseline untill Day 2 (5 hours post-dose)
description: A formal comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to and including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used. The model was fitted using an unstructured variance-covariance matrix.
The individual pair-wise comparisons were reported (comparison in least square [LS] means for 9.0 mg/kg versus placebo; 6.0mg/kg versus placebo; 3.0 mg/kg versus placebo).
Evolution over time in Global Severity Score. The maximum total score is 20 (minimum:0 to manimum:20); higher score indicates more severe disease.
measure: Time-to-Clinical Response
time frame: Overall Study Period (i.e., approximately 28 days)
description: The time-to-clinical response was defined as the time between the first study drug administration and the time of achieving adequate oxygen saturation (defined as SpO2 > 92% over a period of at least 4 hours) and adequate oral feeding (which is sufficient to maintain sufficient hydration, in the judgment of the Investigator).
measure: Time-to-BQL (RT-qPCR)
time frame: Overall Study Period (i.e., approximately 28 days)
description: As secondary endpoint, the time-to-BQL using RT-qPCR was summarized using Kaplan Meier (KM) estimates. No p-values were calculated. For RSV load by RT-qPCR, the lower limit of quantification (LLOQ) was 2.4 log10 copies/mL.
The upper limit confidence interval (CI) could not be calculated; Values of the 25 percentile are reported here.
measure: Time-to-undetectable Viral Load (Plaque Assay Analysis)
time frame: Overall Study Period (i.e., approximately 28 days)
description: The time-to-undetectability (hours), defined as the time from the first study drug administration to the first occurrence of viral titer below the lower limit of quantification (LLOQ), and target not detected provided the next measured value was also below the quantification limit and undetected, were summarized using KM estimates, based on the plaque assay. The time-to-event for subjects with missing data and/or subjects who did not reach undetectability during the trial were censored at the last non-missing viral load assessment. For RSV load by plaque assay the LLOQ was 1.7 log10 pfu/mL.
measure: Viral Load Changes From Baseline (Plaque Assay Analysis)
time frame: From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)
description: Change from Baseline in RSV Load measured by Plaque Assay (RSV Infected Population)
measure: Viral Load Changes From Baseline (RT-qPCR Analysis)
time frame: From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)
description: Change from Baseline in RSV Load measured by RT-qPCR (RSV Infected Population)
measure: Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis)
time frame: From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)
description: The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t<x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.
measure: Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis)
time frame: From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)
description: The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t<x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.
measure: Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies
time frame: Overall Study Period (i.e., approximately 28 days)
description: The number of subjects with treatment-emergent (TE) anti-drug antibodies (ADA; TE ADA) based on ADA assay by treatment group for the Safety Population. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.
Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.
measure: Immunogenicity; Number of Subjects With Treatment-emergent Neutralizing Antibodies
time frame: Overall Study Period (i.e., approximately 28 days)
description: Number of subjects with treatment-emergent neutralizing antibodies (TE NAb) as detected with the competitive ligand binding NAb assay. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.
Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.
arm group label: ALX-0171 3.0 mg/kg
arm group type: Experimental
description: Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days
arm group label: ALX-0171 6.0 mg/kg
arm group type: Experimental
description: Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days
arm group label: ALX-0171 Dose 9.0mg/kg
arm group type: Experimental
description: Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days
arm group label: Placebo
arm group type: Placebo Comparator
description: Inhalation of Placebo once daily for 3 consecutive days
intervention type: Biological
intervention name: ALX-0171 3.0 mg/kg
arm group label: ALX-0171 3.0 mg/kg
intervention type: Biological
intervention name: ALX-0171 6.0 mg/kg
arm group label: ALX-0171 6.0 mg/kg
intervention type: Biological
intervention name: ALX-0171 9.0 mg/kg
arm group label: ALX-0171 Dose 9.0mg/kg
intervention type: Other
intervention name: Placebo
arm group label: Placebo
other name: Matching Placebo
criteria: 
gender: All
minimum age: 28 Days
maximum age: 2 Years
healthy volunteers: No
last name: Ablynx Clinical Department
role: Study Director
affiliation: Ablynx, a Sanofi company
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country: Belgium
country: Bulgaria
country: Chile
country: Colombia
country: Croatia
country: Czechia
country: Estonia
country: Germany
country: Hungary
country: Israel
country: Latvia
country: Malaysia
country: Philippines
country: Poland
country: Slovakia
country: Spain
country: Thailand
country: Brazil
country: Lithuania
country: South Africa
country: United Kingdom
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Gontivimab
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 