<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01691820</url>
  </required_header>
  <id_info>
    <org_study_id>115639</org_study_id>
    <nct_id>NCT01691820</nct_id>
  </id_info>
  <brief_title>A Study in Adolescent Females to Explore Cytomegalovirus Infection</brief_title>
  <official_title>A Study in Adolescent Females to Explore Cytomegalovirus Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to estimate the incidence of Cytomegalovirus (CMV) secondary&#xD;
      infections (re-infections/re-activations) and the incidence of CMV primary infections in&#xD;
      adolescent females.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2012</start_date>
  <completion_date type="Actual">April 8, 2017</completion_date>
  <primary_completion_date type="Actual">April 8, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</measure>
    <time_frame>At Month 4</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</measure>
    <time_frame>At Month 8</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</measure>
    <time_frame>At Month 12</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</measure>
    <time_frame>At Month 16</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</measure>
    <time_frame>At Month 20</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</measure>
    <time_frame>At Month 24</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</measure>
    <time_frame>At Month 28</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</measure>
    <time_frame>At Month 32</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</measure>
    <time_frame>At Month 36</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</measure>
    <time_frame>At Month 0</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</measure>
    <time_frame>At Month 4</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</measure>
    <time_frame>At Month 8</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</measure>
    <time_frame>At Month 12</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</measure>
    <time_frame>At Month 16</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</measure>
    <time_frame>At Month 20</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</measure>
    <time_frame>At Month 24</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</measure>
    <time_frame>At Month 28</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</measure>
    <time_frame>At Month 32</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</measure>
    <time_frame>At Month 36</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine</measure>
    <time_frame>At Month 4</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;) and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0&lt;DNA copies &lt;LLOQ (6720 copies/mL) in prior urine sample (category name= &quot;≥6720 copies/mL&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</measure>
    <time_frame>At Month 8</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;) and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0&lt;DNA copies &lt;LLOQ (6720 copies/mL) in prior urine sample (category name= &quot;≥6720 copies/mL&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</measure>
    <time_frame>At Month 12</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</measure>
    <time_frame>At Month 16</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</measure>
    <time_frame>At Month 20</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</measure>
    <time_frame>At Month 24</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</measure>
    <time_frame>At Month 28</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;) and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0&lt;DNA copies &lt;LLOQ (6720 copies/mL) in prior urine sample (category name= &quot;≥6720 copies/mL&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</measure>
    <time_frame>At Month 32</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</measure>
    <time_frame>At Month 36</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.</measure>
    <time_frame>From study Month 0 to Month 36</time_frame>
    <description>This outcome was part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegative subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects</measure>
    <time_frame>From study Month 0 to Month 36</time_frame>
    <description>This outcome is part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegatve subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">369</enrollment>
  <condition>Infections, Cytomegalovirus</condition>
  <arm_group>
    <arm_group_label>Group S+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group S-</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Missing serostatus Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with no confirmed serostatus, aged between 10-17 years at enrollment in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood collection</intervention_name>
    <description>Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.</description>
    <arm_group_label>Group S+</arm_group_label>
    <arm_group_label>Group S-</arm_group_label>
    <arm_group_label>Missing serostatus Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Urine collection</intervention_name>
    <description>Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.</description>
    <arm_group_label>Group S+</arm_group_label>
    <arm_group_label>Group S-</arm_group_label>
    <arm_group_label>Missing serostatus Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Saliva collection</intervention_name>
    <description>Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.</description>
    <arm_group_label>Group S+</arm_group_label>
    <arm_group_label>Group S-</arm_group_label>
    <arm_group_label>Missing serostatus Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A female adolescent between, and including 10 and 17 years at the time of enrolment&#xD;
             regardless of pregnancy status and contraception method used or not used.&#xD;
&#xD;
          -  Subjects who the investigator believes that the subject and/or the subject's&#xD;
             parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the&#xD;
             requirements of the protocol.&#xD;
&#xD;
          -  Written informed assent and/or consent obtained from the subject and/or the&#xD;
             parent(s)/LAR(s) of the subject.&#xD;
&#xD;
          -  Subject is likely to remain in the area and/or return for required study Site Visits&#xD;
             and complete Sample Collection Visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child in care.&#xD;
&#xD;
          -  Use or planned use of any investigational or non-registered antiviral drug or vaccine&#xD;
             during the study period.&#xD;
&#xD;
          -  Known medical history of any recurrent clinical herpes episodes requiring episodic or&#xD;
             chronic suppressive treatment with oral or parenteral antiviral treatment such as&#xD;
             acyclovir, famciclovir, valacyclovir or any other anti-herpes virus anti-viral during&#xD;
             the year preceding enrolment. Topical anti-viral are allowed.&#xD;
&#xD;
          -  Subjects with history of previous vaccination against CMV.&#xD;
&#xD;
          -  Chronic administration of immunosuppressants or other immune-modifying drugs within 6&#xD;
             months prior to Visit 1 or planned administration during the study. Inhaled and&#xD;
             topical steroids are allowed.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products within 3 months prior to&#xD;
             Visit 1 or planned administration during the study.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including&#xD;
             HIV-infection, based on medical history and physical examination (no laboratory&#xD;
             testing required).&#xD;
&#xD;
          -  Any major congenital defects, serious chronic illness or organ transplantation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stevensville</city>
        <state>Michigan</state>
        <zip>49127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Helsinki</city>
        <zip>00260</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oulu</city>
        <zip>90220</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jojutla</city>
        <state>Morelos</state>
        <zip>62900</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
  </removed_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>April 5, 2018</results_first_submitted>
  <results_first_submitted_qc>July 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 25, 2019</results_first_posted>
  <last_update_submitted>April 1, 2021</last_update_submitted>
  <last_update_submitted_qc>April 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent females</keyword>
  <keyword>Cytomegalovirus (CMV)</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>Cytomegalovirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 19, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT01691820/Prot_001.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>February 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT01691820/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrolment was terminated once approximately 240 seropositive subjects were included in the trial, to obtain approximately 200 evaluable seropositive subjects. The number of seronegative subjects enrolled depended on the seroprevalence of the participating countries.</recruitment_details>
      <pre_assignment_details>Of the 369 enrolled subjects, 363 were female subjects and 6 were newborns of some subjects. Consent was signed for the newborns to allow testing for CMV disease. The objectives assessed the CMV infections in the adolescent females with a known serostatus (N=362); no demographics, outcome measures, or adverse events were assessed in newborns.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group S+</title>
          <description>Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.</description>
        </group>
        <group group_id="P2">
          <title>Group S-</title>
          <description>Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="210"/>
                <participants group_id="P2" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="184"/>
                <participants group_id="P2" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Consent withdrawal (not due to an AE)</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Migrated/moved from study area</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other (unspecified)</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The primary and secondary objectives of this study have assessed the incidence of CMV infections in adolescent females only, hence no demographic data was collected for the 6 newborns.</population>
      <group_list>
        <group group_id="B1">
          <title>Group S+</title>
          <description>CMV seropositive subjects, aged 10-17 years at enrollment in the study.</description>
        </group>
        <group group_id="B2">
          <title>Group S-</title>
          <description>CMV seronegative subjects, aged 10-17 years at enrollment in the study.</description>
        </group>
        <group group_id="B3">
          <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="210"/>
            <count group_id="B2" value="152"/>
            <count group_id="B3" value="362"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.5" spread="2.1"/>
                    <measurement group_id="B2" value="13.4" spread="2.2"/>
                    <measurement group_id="B3" value="13.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="210"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="362"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African Heritage / African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Arabic / North African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Caucasian / European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="137"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
        <time_frame>At Month 4</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results at Month 4 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
          <population>This analysis was performed on CMV seropositive subjects with available results at Month 4 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</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="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>anti-Teg IgG - Two-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-Teg IgG -Four-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
        <time_frame>At Month 8</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results at Month 8 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrolment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
          <population>This analysis was performed on CMV seropositive subjects with available results at Month 8 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</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="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Two-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Four-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
        <time_frame>At Month 12</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results at Month 12 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrolment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
          <population>This analysis was performed on CMV seropositive subjects with available results at Month 12 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</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="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Two-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Four-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
        <time_frame>At Month 16</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results at Month 16 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
          <population>This analysis was performed on CMV seropositive subjects with available results at Month 16 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</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="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Two-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Four-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
        <time_frame>At Month 20</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results at Month 20 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
          <population>This analysis was performed on CMV seropositive subjects with available results at Month 20 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</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="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Two-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Four-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
        <time_frame>At Month 24</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results at Month 24 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
          <population>This analysis was performed on CMV seropositive subjects with available results at Month 24 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</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="189"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Two-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Four-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
        <time_frame>At Month 28</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results at Month 28 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
          <population>This analysis was performed on CMV seropositive subjects with available results at Month 28 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</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="188"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Two-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Four-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
        <time_frame>At Month 32</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results at Month 32 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
          <population>This analysis was performed on CMV seropositive subjects with available results at Month 32 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</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="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Two-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Four-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
        <time_frame>At Month 36</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results at Month 36 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases&quot; category = subjects that had two-fold and above increases of anti-CMV IgG concentration. &quot;Four-fold and above increases&quot; = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.</description>
          <population>This analysis was performed on CMV seropositive subjects with available results at Month 36 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Two-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Four-fold and above increases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.</description>
        <time_frame>At Month 0</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results at Month 0 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.</description>
          <population>This analysis was performed on CMV seropositive subjects with available results at Month 0 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="4.9" upper_limit="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
        <time_frame>At Month 4</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 4, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects, aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
          <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 4, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2" lower_limit="14.4" upper_limit="72.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
        <time_frame>At Month 8</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 8, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
          <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 8, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" lower_limit="2.8" upper_limit="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
        <time_frame>At Month 12</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 12, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
          <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 12, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" lower_limit="2.7" upper_limit="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
        <time_frame>At Month 16</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 16, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects, aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
          <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 16, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.5" lower_limit="NA" upper_limit="NA">No Upper or Lower limits could be computed since there was only 1 subject who met the criterion.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
        <time_frame>At Month 20</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 20, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects, aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
          <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 20, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" lower_limit="3.7" upper_limit="27.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
        <time_frame>At Month 24</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 24, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
          <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 24, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" lower_limit="5.4" upper_limit="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point)</description>
        <time_frame>At Month 28</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 28, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects, aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point)</description>
          <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 28, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="2.4" upper_limit="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
        <time_frame>At Month 32</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 32, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
          <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 32, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" lower_limit="NA" upper_limit="NA">No Upper or Lower limits could be computed since there was only 1 subject who met the criterion.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
        <time_frame>At Month 36</time_frame>
        <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 36, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).</description>
          <population>This analysis was performed on CMV seropositive subjects with available results and meeting the two-fold increase or above, at Month 36, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="2.0" upper_limit="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;) and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0&lt;DNA copies &lt;LLOQ (6720 copies/mL) in prior urine sample (category name= &quot;≥6720 copies/mL&quot;).</description>
        <time_frame>At Month 4</time_frame>
        <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 4, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;) and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0&lt;DNA copies &lt;LLOQ (6720 copies/mL) in prior urine sample (category name= &quot;≥6720 copies/mL&quot;).</description>
          <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 4, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>DNA copies/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt; 0 Copies/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="754.1" lower_limit="144.6" upper_limit="3932.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 6720 Copies/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8310.0" lower_limit="NA" upper_limit="NA">No Upper or Lower limits could be computed since there was only 1 subject in this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;) and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0&lt;DNA copies &lt;LLOQ (6720 copies/mL) in prior urine sample (category name= &quot;≥6720 copies/mL&quot;).</description>
        <time_frame>At Month 8</time_frame>
        <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 8, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CCMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;) and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0&lt;DNA copies &lt;LLOQ (6720 copies/mL) in prior urine sample (category name= &quot;≥6720 copies/mL&quot;).</description>
          <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 8, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>DNA copies/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt; 0 Copies/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="361.5" lower_limit="166.9" upper_limit="783.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 6720 Copies/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15386.0" lower_limit="NA" upper_limit="NA">No Upper or Lower limits could be computed since there was only 1 subject in this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
        <time_frame>At Month 12</time_frame>
        <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 12, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive, adolescent females aged between 10 and 17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
          <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 12, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
          <units>DNA copies/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="647.4" lower_limit="213.1" upper_limit="1966.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
        <time_frame>At Month 16</time_frame>
        <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 16, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive, adolescent females aged between 10 and 17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
          <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 16, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
          <units>DNA copies/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="348.7" lower_limit="129.8" upper_limit="936.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
        <time_frame>At Month 20</time_frame>
        <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 20, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive, adolescent females aged between 10 and 17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
          <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 20, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
          <units>DNA copies/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="199.4" lower_limit="97.5" upper_limit="408.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
        <time_frame>At Month 24</time_frame>
        <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 24,from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
          <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 24,from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
          <units>DNA copies/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="322.1" lower_limit="112.8" upper_limit="919.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;) and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0&lt;DNA copies &lt;LLOQ (6720 copies/mL) in prior urine sample (category name= &quot;≥6720 copies/mL&quot;).</description>
        <time_frame>At Month 28</time_frame>
        <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 28,from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;) and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0&lt;DNA copies &lt;LLOQ (6720 copies/mL) in prior urine sample (category name= &quot;≥6720 copies/mL&quot;).</description>
          <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 28,from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
          <units>DNA copies/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt; 0 Copies/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="421.9" lower_limit="71.3" upper_limit="2497.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 6720 Copies/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7369.0" lower_limit="NA" upper_limit="NA">No Upper or Lower limits could be computed since there was only 1 subject in this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
        <time_frame>At Month 32</time_frame>
        <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 32, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
          <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 32, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
          <units>DNA copies/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="186.1" lower_limit="15.0" upper_limit="2308.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
        <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
        <time_frame>At Month 36</time_frame>
        <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 36, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
        <group_list>
          <group group_id="O1">
            <title>Group S+</title>
            <description>CMV seropositive subjects aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine</title>
          <description>This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (&gt;0 copies/mL) and DNA copies=0 in prior urine sample (category=&quot;&gt; 0 Copies/mL&quot;).</description>
          <population>This analysis was performed on the seropositive subjects with DNA copies data in prior urine sample and with CMV DNA copies above the specified cut-off, at Month 36, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures</population>
          <units>DNA copies/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="915.3" lower_limit="123.0" upper_limit="6808.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
        <description>This outcome was part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegative subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment.</description>
        <time_frame>From study Month 0 to Month 36</time_frame>
        <population>This analysis was performed on the seronegative subjects with available results at the specified timepoints, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S-</title>
            <description>CMV seronegative subjects, aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.</title>
          <description>This outcome was part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegative subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment.</description>
          <population>This analysis was performed on the seronegative subjects with available results at the specified timepoints, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</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="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects</title>
        <description>This outcome is part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegatve subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.</description>
        <time_frame>From study Month 0 to Month 36</time_frame>
        <population>This analysis was performed on the seronegative subjects with available results at Month 0, or on the seronegative subjects with antibody concentration above 1.136 U/mL for the other time points, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>Group S-</title>
            <description>CMV seronegative subjects, aged between 10-17 years at enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects</title>
          <description>This outcome is part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegatve subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.</description>
          <population>This analysis was performed on the seronegative subjects with available results at Month 0, or on the seronegative subjects with antibody concentration above 1.136 U/mL for the other time points, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.3" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" lower_limit="0.8" upper_limit="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="0.8" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="0.5" upper_limit="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="1.2" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="2.2" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" lower_limit="1.5" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="1.4" upper_limit="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="1.7" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="2.1" upper_limit="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events were collected throughout the entire study, from Month 0 up to Month 36.</time_frame>
      <desc>There were no Other (Not Including Serious) Adverse Events collected in this study, as there were no vaccines administered.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group S+</title>
          <description>CMV seropositive subjects aged 10-17 years at enrollment in the study.</description>
        </group>
        <group group_id="E2">
          <title>Group S-</title>
          <description>CMV seronegative subjects aged 10-17 years at enrollment in the study.</description>
        </group>
      </group_list>
      <serious_events>
        <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="210"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>biliana.v.nestorova@gsk.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/NCT01691820
org study id: 115639
nct id: NCT01691820
lead sponsor: 
The purpose of this study is to estimate the incidence of Cytomegalovirus (CMV) secondary
      infections (re-infections/re-activations) and the incidence of CMV primary infections in
      adolescent females.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
time frame: At Month 4
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
time frame: At Month 8
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
time frame: At Month 12
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
time frame: At Month 16
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
time frame: At Month 20
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
time frame: At Month 24
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
time frame: At Month 28
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
time frame: At Month 32
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
measure: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.
time frame: At Month 36
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV.
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
time frame: At Month 0
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
time frame: At Month 4
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
time frame: At Month 8
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
time frame: At Month 12
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
time frame: At Month 16
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
time frame: At Month 20
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
time frame: At Month 24
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
time frame: At Month 28
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point)
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
time frame: At Month 32
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
measure: Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).
time frame: At Month 36
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that had two-fold and above increases [including four-fold] of CMV anti-tegument IgG compared with previous time point).
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine
time frame: At Month 4
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
time frame: At Month 8
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
time frame: At Month 12
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
time frame: At Month 16
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
time frame: At Month 20
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
time frame: At Month 24
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
time frame: At Month 28
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL") and for CMV seropositive subjects with increase of CMV DNA (≥6720 copies/mL) and 0<DNA copies <LLOQ (6720 copies/mL) in prior urine sample (category name= "≥6720 copies/mL").
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
time frame: At Month 32
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
measure: Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine
time frame: At Month 36
description: This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR),for CMV seropositive subjects with appearance of CMV DNA (>0 copies/mL) and DNA copies=0 in prior urine sample (category="> 0 Copies/mL").
measure: Number of CMV Seronegative Subjects With Appearance of Anti-CMV Tegument Protein IgG Antibodies in Serum.
time frame: From study Month 0 to Month 36
description: This outcome was part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegative subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment.
measure: Anti-CMV Tegument Protein IgG Antibody Concentration of Seronegative Subjects
time frame: From study Month 0 to Month 36
description: This outcome is part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegatve subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.
arm group label: Group S+
arm group type: Experimental
description: Cytomegalovirus (CMV) seropositive subjects aged between 10-17 years at enrollment in the study.
arm group label: Group S-
arm group type: Experimental
description: Cytomegalovirus (CMV) seronegative subjects aged between 10-17 years at enrollment in the study.
arm group label: Missing serostatus Group
arm group type: Experimental
description: Subjects with no confirmed serostatus, aged between 10-17 years at enrollment in the study.
intervention type: Procedure
intervention name: Blood collection
description: Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
arm group label: Group S+
arm group label: Group S-
arm group label: Missing serostatus Group
intervention type: Procedure
intervention name: Urine collection
description: Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
arm group label: Group S+
arm group label: Group S-
arm group label: Missing serostatus Group
intervention type: Procedure
intervention name: Saliva collection
description: Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
arm group label: Group S+
arm group label: Group S-
arm group label: Missing serostatus Group
criteria: 
gender: Female
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Finland
country: Mexico
country: United States
country: Brazil
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Cytomegalovirus Infections
sharing ipd: No
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