<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02256631</url>
  </required_header>
  <id_info>
    <org_study_id>IMPAACT P1112</org_study_id>
    <secondary_id>11903</secondary_id>
    <nct_id>NCT02256631</nct_id>
  </id_info>
  <brief_title>Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants</brief_title>
  <official_title>Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to assess the safety and pharmacokinetics (PK) of three&#xD;
      monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at&#xD;
      increased risk of mother-to-child HIV transmission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      VRC01, VRC01LS, and VRC07-523LS are anti-HIV neutralizing monoclonal antibodies that may help&#xD;
      prevent mother-to-child transmission of HIV. This study enrolled HIV-infected mothers who&#xD;
      were at increased risk of passing HIV on to their children. The purpose of this study was to&#xD;
      assess the safety and PK of VRC01, VRC01LS, and VRC07-523LS in HIV-exposed infants.&#xD;
&#xD;
      This study enrolled mother-infant pairs into five dose groups. Infants enrolled in Dose Group&#xD;
      1 and Dose Group 2 received a single VRC01 injection less than 72 hours after birth. Infants&#xD;
      in Dose Group 3 received a VRC01 injection less than 5 days after birth, followed by VRC01&#xD;
      injections monthly for at least 6 months and no more than 18 months, while breastfeeding.&#xD;
&#xD;
      Dose Groups 4 and 5 each enrolled infants into two cohorts: Cohort 1 (non-breastfeeding) or&#xD;
      Cohort 2 (breastfeeding). Infants in Dose Group 4, Cohort 1 received a single VRC01LS&#xD;
      injection less than 72 hours after birth. Infants in Dose Group 4, Cohort 2 received an&#xD;
      initial VRC01LS injection no longer than 5 days after birth, and a second VRC01LS injection&#xD;
      at Week 12 if they were still breastfeeding. Infants in Dose Group 5, Cohort 1 received a&#xD;
      single VRC07-523LS injection less than 72 hours after birth. Infants in Dose Group 5, Cohort&#xD;
      2 received an initial VRC07-523LS injection no longer than 5 days after birth, and a second&#xD;
      VRC07-523LS injection at Week 12 if they were still breastfeeding.&#xD;
&#xD;
      The mothers did not receive any VRC01, VRC01LS, or VRC07-523LS injections. At study entry,&#xD;
      all mothers underwent a medical history review and a blood collection, and then the study&#xD;
      ended for the mothers.&#xD;
&#xD;
      Infants in Dose Groups 1 and 2 attended study visits at days 0, 1, 3, 7, 14, 28 and at weeks&#xD;
      8, 16, 24, and 48. Infants in Dose Group 3 attended study visits at days 0, 1, 14, 28 and at&#xD;
      weeks 8, 12, 16, 20, 24, and every 4 weeks until cessation of breastfeeding or week 72, then&#xD;
      at weeks 84 and 96. Infants in Dose Group 4 attended study visits at days 0, 1, 14, 28 and at&#xD;
      weeks 8, 12, 24, 36, 48, 60, 72, 84 and 96, with additional visits at weeks 14 and 16 for&#xD;
      Cohort 2 participants. Infants in Dose Group 5 attended study visits at days 0, 1, 3, 7, 14,&#xD;
      28 and at weeks 8, 12, 24, 36, 48, 60, 72, 84 and 96, with additional visits at weeks 14 and&#xD;
      16 for Cohort 2 participants. Visits included a medical history review, physical examination,&#xD;
      blood collection, and oral fluid collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2015</start_date>
  <completion_date type="Actual">December 16, 2021</completion_date>
  <primary_completion_date type="Actual">June 17, 2020</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Died</measure>
    <time_frame>From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE)</measure>
    <time_frame>From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE)</measure>
    <time_frame>From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed and determined if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Diagnosed With HIV Infection</measure>
    <time_frame>From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. HIV diagnoses from day 0 to 4 weeks after the participants' last immunization were included.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Groups 1, 2, 3 and 4</measure>
    <time_frame>Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-28 days (area-under-the-curve from 0 to 28 days) for Dose Groups 1, 2 and 3 and AUC0-84 days for Dose Group 4, were determined using the linear trapezoidal rule. Median and range were summarized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Group 5</measure>
    <time_frame>Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-84 days (area-under-the-curve from 0 to 84 days) were determined using the linear trapezoidal rule. Median and range were summarized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (PK) Parameter: Concentration for Dose Groups 1, 2, 3 and 4</measure>
    <time_frame>Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C28 days (concentration at 28 days) for Dose Groups 1, 2 and 3 and C84 days for Dose Group 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (PK) Parameter: Concentration for Dose Group 5</measure>
    <time_frame>Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C84 days (concentration at 84 days).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Died After Last Immunization for Dose Groups 1, 2, 3 and 4</measure>
    <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Group 3 and 4).</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Died After Last Immunization for Dose Group 5</measure>
    <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Groups 1, 2, 3 and 4</measure>
    <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Group 5</measure>
    <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Groups 1, 2, 3, and 4</measure>
    <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Group 5</measure>
    <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Groups 1, 2, 3, and 4</measure>
    <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Group 5</measure>
    <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Developed Anti-VRC Antibodies</measure>
    <time_frame>At weeks 24 and 48.</time_frame>
    <description>The Overall Number of Participants Analyzed represents infants with samples collected and tested. The number of infants who developed anti antibodies to the study products are summarized. For Dose Groups 1, 2, and 3, these are anti-VRC01 antibodies. For Dose Group 4, these are anti-VCR07 antibodies and for Dose Group 5, these are anti-VRC07-523LS antibodies.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Dose Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 4, Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 4, Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 5, Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 5, Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VRC01</intervention_name>
    <description>Administered by subcutaneous injection in the thigh</description>
    <arm_group_label>Dose Group 1</arm_group_label>
    <arm_group_label>Dose Group 2</arm_group_label>
    <arm_group_label>Dose Group 3</arm_group_label>
    <other_name>VRC-HIVMAB-060-00-AB</other_name>
    <other_name>VRC01 mAb</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VRC01LS</intervention_name>
    <description>Administered by subcutaneous injection in the thigh</description>
    <arm_group_label>Dose Group 4, Cohort 1</arm_group_label>
    <arm_group_label>Dose Group 4, Cohort 2</arm_group_label>
    <other_name>VRC-HIVMAB080-00-AB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VRC07-523LS</intervention_name>
    <description>Administered by subcutaneous injection in the thigh</description>
    <arm_group_label>Dose Group 5, Cohort 1</arm_group_label>
    <arm_group_label>Dose Group 5, Cohort 2</arm_group_label>
    <other_name>VRC-HIVMAB075-00-AB</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Maternal Inclusion Criteria:&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Greater than or equal to 18 years of age&#xD;
&#xD;
          -  Able and willing to provide signed informed consent for herself and her infant&#xD;
&#xD;
        Maternal Exclusion Criteria:&#xD;
&#xD;
          -  Prior participation in any HIV-1 vaccine trial&#xD;
&#xD;
          -  Receipt of any other active or passive HIV immunotherapy or investigational product&#xD;
             during this pregnancy. (Note that administration of Food and Drug Administration&#xD;
             [FDA]-approved antiretroviral (ARV) drugs when used to treat disease or prevent&#xD;
             mother-to-child transmission were not considered investigational.)&#xD;
&#xD;
          -  Documented or suspected serious medical illness or immediate life-threatening&#xD;
             condition (other than HIV infection) in the mother that may have interfered with the&#xD;
             ability to complete study requirements, as judged by the examining clinician&#xD;
&#xD;
        Infant Inclusion Criteria:&#xD;
&#xD;
          -  Born to an HIV-1-infected woman who met all maternal inclusion/exclusion criteria&#xD;
             listed above&#xD;
&#xD;
          -  Gestational age, by best obstetrical, ultrasound, or infant exam, greater than or&#xD;
             equal to 36 weeks&#xD;
&#xD;
          -  Birth weight greater than or equal to 2.0 kg&#xD;
&#xD;
          -  Allowable infant age at the time of enrollment was dependent on the Dose Group and&#xD;
             Cohort:&#xD;
&#xD;
               -  Dose Groups 1, 2, 4 and 5 (Cohort 1): Less than 72 hours of age, and anticipated&#xD;
                  availability to receive VRC immunization at less than 72 hours after birth.&#xD;
&#xD;
               -  Dose Groups 3, 4 and 5 (Cohort 2): Less than or equal to 5 days of age, and&#xD;
                  anticipated availability to receive VRC immunization no more than 5 days after&#xD;
                  birth.&#xD;
&#xD;
          -  At increased risk of HIV acquisition defined as documentation of one or more of the&#xD;
             following risk factors:&#xD;
&#xD;
          -  Dose Groups 1, 2, 4 and 5 (Cohort 1), only:&#xD;
&#xD;
               -  Mother received no antiretroviral therapy (ART) during pregnancy or mother began&#xD;
                  or reinitiated ART (after an interruption of greater than 14 days), during the&#xD;
                  third trimester of pregnancy; or&#xD;
&#xD;
               -  Mother with any detectable viral replication (HIV RNA above the limit of&#xD;
                  detection) at last measurement prior to delivery determined within 30 days of&#xD;
                  delivery; or&#xD;
&#xD;
               -  Prolonged rupture of membranes (greater than 12 hours); or&#xD;
&#xD;
               -  Mother with documented 2-class resistant HIV infection, which may have included&#xD;
                  historical documentation of lack of response&#xD;
&#xD;
                    -  Women who had a documented history of virologic failure while on&#xD;
                       non-nucleoside reverse transcriptase inhibitors (NNRTIs) but who had no&#xD;
                       resistance testing at the time of viral failure were considered to have&#xD;
                       NNRTI-documented resistance.&#xD;
&#xD;
          -  Dose Groups 3, 4 and 5 (Cohort 2), only (African sites):&#xD;
&#xD;
               -  Mother intended to breastfeed&#xD;
&#xD;
        Infant Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of any other active or passive HIV immunotherapy or investigational product&#xD;
             other than the study vaccine (Note: Infant prophylaxis with any licensed ARV drugs&#xD;
             clinically prescribed to prevent mother-to-child HIV transmission were not considered&#xD;
             investigational.)&#xD;
&#xD;
          -  Receipt of or anticipated need for blood products, immunoglobulin, or&#xD;
             immunosuppressive therapy. This included infants who required hepatitis B&#xD;
             immunoglobulin (HBIG) but did not require exclusion of infants who received hepatitis&#xD;
             B vaccine in the newborn period.&#xD;
&#xD;
          -  Documented or suspected serious medical illness, serious congenital anomaly, or&#xD;
             immediate life-threatening condition in the infant that may have interfered with the&#xD;
             ability to complete study requirements, as judged by the examining clinician&#xD;
&#xD;
          -  Any requirement for supplemental oxygen beyond 24 hours of life or requiring&#xD;
             supplemental oxygen at the time of the VRC01, VRC01LS, or VRC07-523LS dose&#xD;
&#xD;
          -  Baseline laboratory results:&#xD;
&#xD;
               -  Hemoglobin less than 12.0 g/dL&#xD;
&#xD;
               -  Platelet count less than 100,000 cells/mm^3&#xD;
&#xD;
               -  Absolute neutrophil count: for infants less than or equal to 24 hours old, less&#xD;
                  than 4,000 cells/mm^3; for infants greater than 24 hours old, less than 1,250&#xD;
                  cells/mm^3&#xD;
&#xD;
               -  Serum glutamic pyruvic transaminase (SGPT) greater than or equal to 1.25 times&#xD;
                  upper limit of age adjusted normal&#xD;
&#xD;
          -  Dose Groups 1, 2, 4 and 5 (Cohort 1), only: Infant was breastfeeding at time of&#xD;
             enrollment or mother had indicated an intention to initiate breastfeeding. Note: if a&#xD;
             child was breastfed prior to known maternal diagnosis (in the case of a woman&#xD;
             diagnosed in the intrapartum period), the child was still eligible as long as&#xD;
             breastfeeding was stopped by the time the child was enrolled and there was no plan to&#xD;
             resume breast milk feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Days</minimum_age>
    <maximum_age>5 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Coleen Cunningham, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>David Geffen School of Medicine at UCLA NICHD CRS</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-1752</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. of Colorado Denver NICHD CRS</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida CDTC Ft Lauderdale NICHD CRS</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. of Florida Jacksonville NICHD CRS</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Perinatal HIV Clinical Trials Unit CRS</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine NICHD CRS</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Univ. Baltimore NICHD CRS</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronx-Lebanon Hospital Center NICHD CRS</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10457</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacobi Med. Ctr. Bronx NICHD CRS</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital CRS</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-2399</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Puerto Rico Pediatric HIV/AIDS Research Program CRS</name>
      <address>
        <city>San Juan</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Juan City Hosp. PR NICHD CRS</name>
      <address>
        <city>San Juan</city>
        <zip>00936</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Famcru Crs</name>
      <address>
        <city>Tygerberg</city>
        <state>Western Cape Province</state>
        <zip>7505</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harare Family Care CRS</name>
      <address>
        <city>Harare</city>
        <country>Zimbabwe</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>South Africa</country>
    <country>United States</country>
    <country>Zimbabwe</country>
  </location_countries>
  <link>
    <url>http://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf</url>
    <description>Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)</description>
  </link>
  <link>
    <url>http://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids</url>
    <description>Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010</description>
  </link>
  <results_reference>
    <citation>Cunningham CK, McFarland EJ, Morrison RL, Capparelli EV, Safrit JT, Mofenson LM, Mathieson B, Valentine ME, Perlowski C, Smith B, Hazra R, Purdue L, Muresan P, Harding PA, Mbengeranwa T, Robinson LG, Wiznia A, Theron G, Lin B, Bailer RT, Mascola JR, Graham BS; IMPAACT P1112 team. Safety, Tolerability, and Pharmacokinetics of the Broadly Neutralizing Human Immunodeficiency Virus (HIV)-1 Monoclonal Antibody VRC01 in HIV-Exposed Newborn Infants. J Infect Dis. 2020 Jul 23;222(4):628-636. doi: 10.1093/infdis/jiz532.</citation>
    <PMID>31681963</PMID>
  </results_reference>
  <results_reference>
    <citation>McFarland EJ, Cunningham CK, Muresan P, Capparelli EV, Perlowski C, Morgan P, Smith B, Hazra R, Purdue L, Harding PA, Theron G, Mujuru H, Agwu A, Purswani M, Rathore MH, Flach B, Taylor A, Lin BC, McDermott AB, Mascola JR, Graham BS; International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1112 Team. Safety, Tolerability, and Pharmacokinetics of a Long-Acting Broadly Neutralizing Human Immunodeficiency Virus Type 1 (HIV-1) Monoclonal Antibody VRC01LS in HIV-1-Exposed Newborn Infants. J Infect Dis. 2021 Dec 1;224(11):1916-1924. doi: 10.1093/infdis/jiab229.</citation>
    <PMID>34009371</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>June 14, 2021</results_first_submitted>
  <results_first_submitted_qc>July 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 23, 2021</results_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02256631/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02256631/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>83 mother-infant pairs were enrolled in the study. Since the mothers did not receive any treatment on study and were taken off study immediately after enrollment, the number of participants shown in all tables is the number of infants (83). Participants were enrolled from June 2015 to February 2020, at 14 medical clinics in the United States, Puerto Rico, South Africa and Zimbabwe.</recruitment_details>
      <pre_assignment_details>Dose groups enrolled sequentially. There was no randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dose Group 1</title>
          <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="P2">
          <title>Dose Group 2</title>
          <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="P3">
          <title>Dose Group 3</title>
          <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="P4">
          <title>Dose Group 4, Cohort 1</title>
          <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="P5">
          <title>Dose Group 4, Cohort 2</title>
          <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="P6">
          <title>Dose Group 5, Cohort 1</title>
          <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="P7">
          <title>Dose Group 5, Cohort 2</title>
          <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="11"/>
                <participants group_id="P6" count="11"/>
                <participants group_id="P7" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to get to clinic</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics were collected only for infants.</population>
      <group_list>
        <group group_id="B1">
          <title>Dose Group 1</title>
          <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="B2">
          <title>Dose Group 2</title>
          <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="B3">
          <title>Dose Group 3</title>
          <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="B4">
          <title>Dose Group 4, Cohort 1</title>
          <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="B5">
          <title>Dose Group 4, Cohort 2</title>
          <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="B6">
          <title>Dose Group 5, Cohort 1</title>
          <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="B7">
          <title>Dose Group 5, Cohort 2</title>
          <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
        </group>
        <group group_id="B8">
          <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="13"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="11"/>
            <count group_id="B6" value="11"/>
            <count group_id="B7" value="11"/>
            <count group_id="B8" value="83"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Age at first dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B2" value="2" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B3" value="2" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="B4" value="2" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B5" value="2" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="B6" value="1" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B7" value="4" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="B8" value="2" lower_limit="0" upper_limit="5"/>
                  </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="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Puerto Rico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Zimbabwe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Birth Weight</title>
          <units>grams</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3045" lower_limit="2330" upper_limit="4675"/>
                    <measurement group_id="B2" value="3160" lower_limit="2609" upper_limit="3580"/>
                    <measurement group_id="B3" value="2860" lower_limit="2330" upper_limit="4320"/>
                    <measurement group_id="B4" value="2865" lower_limit="2535" upper_limit="4045"/>
                    <measurement group_id="B5" value="2920" lower_limit="2500" upper_limit="3545"/>
                    <measurement group_id="B6" value="2810" lower_limit="2528" upper_limit="3540"/>
                    <measurement group_id="B7" value="3235" lower_limit="2260" upper_limit="4375"/>
                    <measurement group_id="B8" value="2920" lower_limit="2260" upper_limit="4675"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Died</title>
        <description>The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included.</description>
        <time_frame>From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)</time_frame>
        <population>All infant study participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O6">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O7">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Died</title>
          <description>The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included.</description>
          <population>All infant study participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="11"/>
                <count group_id="O7" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="19"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="26"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O6" value="0" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O7" value="0" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE)</title>
        <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.</description>
        <time_frame>From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)</time_frame>
        <population>All infant study participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O6">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O7">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE)</title>
          <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.</description>
          <population>All infant study participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="11"/>
                <count group_id="O7" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="11" upper_limit="57"/>
                    <measurement group_id="O2" value="14" lower_limit="3" upper_limit="39"/>
                    <measurement group_id="O3" value="31" lower_limit="11" upper_limit="57"/>
                    <measurement group_id="O4" value="10" lower_limit="1" upper_limit="39"/>
                    <measurement group_id="O5" value="27" lower_limit="8" upper_limit="56"/>
                    <measurement group_id="O6" value="36" lower_limit="14" upper_limit="65"/>
                    <measurement group_id="O7" value="9" lower_limit="0" upper_limit="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE)</title>
        <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed and determined if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.</description>
        <time_frame>From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)</time_frame>
        <population>All infant study participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O6">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O7">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE)</title>
          <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed and determined if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.</description>
          <population>All infant study participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="11"/>
                <count group_id="O7" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="19"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="26"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O6" value="0" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O7" value="0" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Diagnosed With HIV Infection</title>
        <description>The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. HIV diagnoses from day 0 to 4 weeks after the participants' last immunization were included.</description>
        <time_frame>From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)</time_frame>
        <population>All infant study participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O6">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O7">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Diagnosed With HIV Infection</title>
          <description>The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. HIV diagnoses from day 0 to 4 weeks after the participants' last immunization were included.</description>
          <population>All infant study participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="11"/>
                <count group_id="O7" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="19"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="26"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O6" value="0" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O7" value="0" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Groups 1, 2, 3 and 4</title>
        <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-28 days (area-under-the-curve from 0 to 28 days) for Dose Groups 1, 2 and 3 and AUC0-84 days for Dose Group 4, were determined using the linear trapezoidal rule. Median and range were summarized.</description>
        <time_frame>Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.</time_frame>
        <population>Infants who received the correct dose and were evaluated for PK at the designated timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Groups 1, 2, 3 and 4</title>
          <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-28 days (area-under-the-curve from 0 to 28 days) for Dose Groups 1, 2 and 3 and AUC0-84 days for Dose Group 4, were determined using the linear trapezoidal rule. Median and range were summarized.</description>
          <population>Infants who received the correct dose and were evaluated for PK at the designated timepoints.</population>
          <units>mcg*d/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2672" lower_limit="1700" upper_limit="3661"/>
                    <measurement group_id="O2" value="4435" lower_limit="3544" upper_limit="6374"/>
                    <measurement group_id="O3" value="6654" lower_limit="4040" upper_limit="8120"/>
                    <measurement group_id="O4" value="9825" lower_limit="5594" upper_limit="12487"/>
                    <measurement group_id="O5" value="8639" lower_limit="6159" upper_limit="12879"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Group 5</title>
        <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-84 days (area-under-the-curve from 0 to 84 days) were determined using the linear trapezoidal rule. Median and range were summarized.</description>
        <time_frame>Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.</time_frame>
        <population>Participants who received the correct dose and were evaluated for PK at the designated timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Group 5</title>
          <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-84 days (area-under-the-curve from 0 to 84 days) were determined using the linear trapezoidal rule. Median and range were summarized.</description>
          <population>Participants who received the correct dose and were evaluated for PK at the designated timepoints.</population>
          <units>mcg*d/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5358" lower_limit="4180" upper_limit="8835"/>
                    <measurement group_id="O2" value="4462" lower_limit="2840" upper_limit="6044"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK) Parameter: Concentration for Dose Groups 1, 2, 3 and 4</title>
        <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C28 days (concentration at 28 days) for Dose Groups 1, 2 and 3 and C84 days for Dose Group 4.</description>
        <time_frame>Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.</time_frame>
        <population>Infants who received the correct dose and were evaluated for PK at the designated timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) Parameter: Concentration for Dose Groups 1, 2, 3 and 4</title>
          <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C28 days (concentration at 28 days) for Dose Groups 1, 2 and 3 and C84 days for Dose Group 4.</description>
          <population>Infants who received the correct dose and were evaluated for PK at the designated timepoints.</population>
          <units>mcg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.19" lower_limit="16.71" upper_limit="76.56"/>
                    <measurement group_id="O2" value="75.25" lower_limit="47.61" upper_limit="122.59"/>
                    <measurement group_id="O3" value="124.24" lower_limit="62.16" upper_limit="180.22"/>
                    <measurement group_id="O4" value="44.64" lower_limit="30.83" upper_limit="64.22"/>
                    <measurement group_id="O5" value="49.60" lower_limit="23.96" upper_limit="62.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK) Parameter: Concentration for Dose Group 5</title>
        <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C84 days (concentration at 84 days).</description>
        <time_frame>Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.</time_frame>
        <population>Participants who received the correct dose and were evaluated for PK at the designated timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) Parameter: Concentration for Dose Group 5</title>
          <description>The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C84 days (concentration at 84 days).</description>
          <population>Participants who received the correct dose and were evaluated for PK at the designated timepoints.</population>
          <units>mcg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.81" lower_limit="11.90" upper_limit="21.42"/>
                    <measurement group_id="O2" value="19.07" lower_limit="9.48" upper_limit="36.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Died After Last Immunization for Dose Groups 1, 2, 3 and 4</title>
        <description>The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
        <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Group 3 and 4).</time_frame>
        <population>All infants enrolled in these Dose Groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Died After Last Immunization for Dose Groups 1, 2, 3 and 4</title>
          <description>The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
          <population>All infants enrolled in these Dose Groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="19"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="26"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Died After Last Immunization for Dose Group 5</title>
        <description>The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
        <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).</time_frame>
        <population>All infants enrolled in these Dose Groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Died After Last Immunization for Dose Group 5</title>
          <description>The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
          <population>All infants enrolled in these Dose Groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Groups 1, 2, 3 and 4</title>
        <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
        <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).</time_frame>
        <population>All infants enrolled in these Dose Groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Groups 1, 2, 3 and 4</title>
          <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
          <population>All infants enrolled in these Dose Groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" lower_limit="7" upper_limit="49"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="19"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O4" value="20" lower_limit="4" upper_limit="51"/>
                    <measurement group_id="O5" value="18" lower_limit="3" upper_limit="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Group 5</title>
        <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
        <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).</time_frame>
        <population>All infants enrolled in these Dose Groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Group 5</title>
          <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
          <population>All infants enrolled in these Dose Groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" lower_limit="3" upper_limit="47"/>
                    <measurement group_id="O2" value="27" lower_limit="8" upper_limit="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Groups 1, 2, 3, and 4</title>
        <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
        <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).</time_frame>
        <population>All infants enrolled in these Dose Groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Groups 1, 2, 3, and 4</title>
          <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
          <population>All infants enrolled in these Dose Groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="19"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="26"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Group 5</title>
        <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
        <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).</time_frame>
        <population>All infants enrolled in these Dose Groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Group 5</title>
          <description>The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
          <population>All infants enrolled in these Dose Groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Groups 1, 2, 3, and 4</title>
        <description>The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
        <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).</time_frame>
        <population>All infants enrolled in these Dose Groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Groups 1, 2, 3, and 4</title>
          <description>The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.</description>
          <population>All infants enrolled in these Dose Groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="19"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="26"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Group 5</title>
        <description>The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
        <time_frame>From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).</time_frame>
        <population>All infants enrolled in these Dose Groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Group 5</title>
          <description>The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.</description>
          <population>All infants enrolled in these Dose Groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Developed Anti-VRC Antibodies</title>
        <description>The Overall Number of Participants Analyzed represents infants with samples collected and tested. The number of infants who developed anti antibodies to the study products are summarized. For Dose Groups 1, 2, and 3, these are anti-VRC01 antibodies. For Dose Group 4, these are anti-VCR07 antibodies and for Dose Group 5, these are anti-VRC07-523LS antibodies.</description>
        <time_frame>At weeks 24 and 48.</time_frame>
        <population>Infant study participants with samples collected and tested.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O3">
            <title>Dose Group 3</title>
            <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.&#xD;
VRC01: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O4">
            <title>Dose Group 4, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O5">
            <title>Dose Group 4, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC01LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O6">
            <title>Dose Group 5, Cohort 1</title>
            <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
          <group group_id="O7">
            <title>Dose Group 5, Cohort 2</title>
            <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.&#xD;
VRC07-523LS: Administered by subcutaneous injection in the thigh</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Developed Anti-VRC Antibodies</title>
          <description>The Overall Number of Participants Analyzed represents infants with samples collected and tested. The number of infants who developed anti antibodies to the study products are summarized. For Dose Groups 1, 2, and 3, these are anti-VRC01 antibodies. For Dose Group 4, these are anti-VCR07 antibodies and for Dose Group 5, these are anti-VRC07-523LS antibodies.</description>
          <population>Infant study participants with samples collected and tested.</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="13"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.</time_frame>
      <desc>Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dose Group 1</title>
          <description>Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.</description>
        </group>
        <group group_id="E2">
          <title>Dose Group 2</title>
          <description>Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.</description>
        </group>
        <group group_id="E3">
          <title>Dose Group 3</title>
          <description>Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.</description>
        </group>
        <group group_id="E4">
          <title>Dose Group 4, Cohort 1</title>
          <description>Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.</description>
        </group>
        <group group_id="E5">
          <title>Dose Group 4, Cohort 2</title>
          <description>Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.</description>
        </group>
        <group group_id="E6">
          <title>Dose Group 5, Cohort 1</title>
          <description>Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.</description>
        </group>
        <group group_id="E7">
          <title>Dose Group 5, Cohort 2</title>
          <description>Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>ABO haemolytic disease of newborn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Infantile spitting up</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumonia parainfluenzae viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sepsis neonatal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Neutropenia neonatal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Neonatal tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial septal defect</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Congenital pigmentation disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Congenital umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Naevus flammeus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Phimosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pulmonary artery stenosis congenital</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sickle cell trait</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Strabismus congenital</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dacryostenosis acquired</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Eye discharge</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Periorbital oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Coating in mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Constipation neonatal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Diarrhoea neonatal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Functional gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastrointestinal sounds abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Infantile colic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Infantile spitting up</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Infantile vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Regurgitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Crying</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Drug withdrawal syndrome neonatal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Fever neonatal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ocular icterus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Candida nappy rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Neonatal candida infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ophthalmia neonatorum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pustule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Septic rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tinea capitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Exposure to communicable disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Eyelid abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood bicarbonate</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood bicarbonate decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood calcium increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood glucose decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Breath sounds abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Capillary nail refill test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Carbon dioxide decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Faecal volume decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Liver palpable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Feeding disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia neonatal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypophagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Poor feeding infant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acquired plagiocephaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Growth failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation neonatal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Fontanelle bulging</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Infant irritability</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tremor neonatal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Caput succedaneum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Jaundice neonatal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Neonatal disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Poor weight gain neonatal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Umbilical granuloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Weight decrease neonatal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Selective eating disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Galactorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Genital macule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Genital swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Penile rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Perineal erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Scrotal dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vulvovaginal erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vulvovaginal rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Grunting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Irregular breathing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oropharyngeal plaque</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rales</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rhonchi</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Stridor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Use of accessory respiratory muscles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Eczema infantile</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Erythema toxicum neonatorum</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Exfoliative rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Macule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Milia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rash neonatal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rash vesicular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Skin mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Transient neonatal pustular melanosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Umbilical haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pallor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Melissa Allen, Director, IMPAACT Operations Center</name_or_title>
      <organization>Family Health International (FHI 360)</organization>
      <phone>(919) 405-1429</phone>
      <email>mallen@fhi360.org</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/NCT02256631
org study id: IMPAACT P1112
secondary id: 11903
nct id: NCT02256631
lead sponsor: 
has dmc: Yes
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three
      monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at
      increased risk of mother-to-child HIV transmission.
VRC01, VRC01LS, and VRC07-523LS are anti-HIV neutralizing monoclonal antibodies that may help
      prevent mother-to-child transmission of HIV. This study enrolled HIV-infected mothers who
      were at increased risk of passing HIV on to their children. The purpose of this study was to
      assess the safety and PK of VRC01, VRC01LS, and VRC07-523LS in HIV-exposed infants.

      This study enrolled mother-infant pairs into five dose groups. Infants enrolled in Dose Group
      1 and Dose Group 2 received a single VRC01 injection less than 72 hours after birth. Infants
      in Dose Group 3 received a VRC01 injection less than 5 days after birth, followed by VRC01
      injections monthly for at least 6 months and no more than 18 months, while breastfeeding.

      Dose Groups 4 and 5 each enrolled infants into two cohorts: Cohort 1 (non-breastfeeding) or
      Cohort 2 (breastfeeding). Infants in Dose Group 4, Cohort 1 received a single VRC01LS
      injection less than 72 hours after birth. Infants in Dose Group 4, Cohort 2 received an
      initial VRC01LS injection no longer than 5 days after birth, and a second VRC01LS injection
      at Week 12 if they were still breastfeeding. Infants in Dose Group 5, Cohort 1 received a
      single VRC07-523LS injection less than 72 hours after birth. Infants in Dose Group 5, Cohort
      2 received an initial VRC07-523LS injection no longer than 5 days after birth, and a second
      VRC07-523LS injection at Week 12 if they were still breastfeeding.

      The mothers did not receive any VRC01, VRC01LS, or VRC07-523LS injections. At study entry,
      all mothers underwent a medical history review and a blood collection, and then the study
      ended for the mothers.

      Infants in Dose Groups 1 and 2 attended study visits at days 0, 1, 3, 7, 14, 28 and at weeks
      8, 16, 24, and 48. Infants in Dose Group 3 attended study visits at days 0, 1, 14, 28 and at
      weeks 8, 12, 16, 20, 24, and every 4 weeks until cessation of breastfeeding or week 72, then
      at weeks 84 and 96. Infants in Dose Group 4 attended study visits at days 0, 1, 14, 28 and at
      weeks 8, 12, 24, 36, 48, 60, 72, 84 and 96, with additional visits at weeks 14 and 16 for
      Cohort 2 participants. Infants in Dose Group 5 attended study visits at days 0, 1, 3, 7, 14,
      28 and at weeks 8, 12, 24, 36, 48, 60, 72, 84 and 96, with additional visits at weeks 14 and
      16 for Cohort 2 participants. Visits included a medical history review, physical examination,
      blood collection, and oral fluid collection.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Participants Who Died
time frame: From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)
description: The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included.
measure: Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE)
time frame: From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)
description: The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.
measure: Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE)
time frame: From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)
description: The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed and determined if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.
measure: Percentage of Participants Diagnosed With HIV Infection
time frame: From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)
description: The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. HIV diagnoses from day 0 to 4 weeks after the participants' last immunization were included.
measure: Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Groups 1, 2, 3 and 4
time frame: Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.
description: The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-28 days (area-under-the-curve from 0 to 28 days) for Dose Groups 1, 2 and 3 and AUC0-84 days for Dose Group 4, were determined using the linear trapezoidal rule. Median and range were summarized.
measure: Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Group 5
time frame: Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.
description: The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-84 days (area-under-the-curve from 0 to 84 days) were determined using the linear trapezoidal rule. Median and range were summarized.
measure: Pharmacokinetics (PK) Parameter: Concentration for Dose Groups 1, 2, 3 and 4
time frame: Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.
description: The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C28 days (concentration at 28 days) for Dose Groups 1, 2 and 3 and C84 days for Dose Group 4.
measure: Pharmacokinetics (PK) Parameter: Concentration for Dose Group 5
time frame: Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.
description: The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C84 days (concentration at 84 days).
measure: Percentage of Participants Who Died After Last Immunization for Dose Groups 1, 2, 3 and 4
time frame: From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Group 3 and 4).
description: The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.
measure: Percentage of Participants Who Died After Last Immunization for Dose Group 5
time frame: From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).
description: The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.
measure: Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Groups 1, 2, 3 and 4
time frame: From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).
description: The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.
measure: Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Group 5
time frame: From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).
description: The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.
measure: Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Groups 1, 2, 3, and 4
time frame: From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).
description: The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.
measure: Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Group 5
time frame: From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).
description: The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.
measure: Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Groups 1, 2, 3, and 4
time frame: From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).
description: The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.
measure: Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Group 5
time frame: From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).
description: The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.
measure: Number of Participants Who Developed Anti-VRC Antibodies
time frame: At weeks 24 and 48.
description: The Overall Number of Participants Analyzed represents infants with samples collected and tested. The number of infants who developed anti antibodies to the study products are summarized. For Dose Groups 1, 2, and 3, these are anti-VRC01 antibodies. For Dose Group 4, these are anti-VCR07 antibodies and for Dose Group 5, these are anti-VRC07-523LS antibodies.
arm group label: Dose Group 1
arm group type: Experimental
description: Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
arm group label: Dose Group 2
arm group type: Experimental
description: Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
arm group label: Dose Group 3
arm group type: Experimental
description: Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
arm group label: Dose Group 4, Cohort 1
arm group type: Experimental
description: Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
arm group label: Dose Group 4, Cohort 2
arm group type: Experimental
description: Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
arm group label: Dose Group 5, Cohort 1
arm group type: Experimental
description: Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
arm group label: Dose Group 5, Cohort 2
arm group type: Experimental
description: Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
intervention type: Biological
intervention name: VRC01
description: Administered by subcutaneous injection in the thigh
arm group label: Dose Group 1
arm group label: Dose Group 2
arm group label: Dose Group 3
other name: VRC-HIVMAB-060-00-AB
other name: VRC01 mAb
intervention type: Biological
intervention name: VRC01LS
description: Administered by subcutaneous injection in the thigh
arm group label: Dose Group 4, Cohort 1
arm group label: Dose Group 4, Cohort 2
other name: VRC-HIVMAB080-00-AB
intervention type: Biological
intervention name: VRC07-523LS
description: Administered by subcutaneous injection in the thigh
arm group label: Dose Group 5, Cohort 1
arm group label: Dose Group 5, Cohort 2
other name: VRC-HIVMAB075-00-AB
criteria: 
gender: All
minimum age: 0 Days
maximum age: 5 Days
healthy volunteers: No
last name: Coleen Cunningham, MD
role: Study Chair
affiliation: Duke University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Puerto Rico
country: South Africa
country: United States
country: Zimbabwe
url: http://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf
description: Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)
url: http://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids
description: Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010
citation: Cunningham CK, McFarland EJ, Morrison RL, Capparelli EV, Safrit JT, Mofenson LM, Mathieson B, Valentine ME, Perlowski C, Smith B, Hazra R, Purdue L, Muresan P, Harding PA, Mbengeranwa T, Robinson LG, Wiznia A, Theron G, Lin B, Bailer RT, Mascola JR, Graham BS; IMPAACT P1112 team. Safety, Tolerability, and Pharmacokinetics of the Broadly Neutralizing Human Immunodeficiency Virus (HIV)-1 Monoclonal Antibody VRC01 in HIV-Exposed Newborn Infants. J Infect Dis. 2020 Jul 23;222(4):628-636. doi: 10.1093/infdis/jiz532.
PMID: 31681963
citation: McFarland EJ, Cunningham CK, Muresan P, Capparelli EV, Perlowski C, Morgan P, Smith B, Hazra R, Purdue L, Harding PA, Theron G, Mujuru H, Agwu A, Purswani M, Rathore MH, Flach B, Taylor A, Lin BC, McDermott AB, Mascola JR, Graham BS; International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1112 Team. Safety, Tolerability, and Pharmacokinetics of a Long-Acting Broadly Neutralizing Human Immunodeficiency Virus Type 1 (HIV-1) Monoclonal Antibody VRC01LS in HIV-1-Exposed Newborn Infants. J Infect Dis. 2021 Dec 1;224(11):1916-1924. doi: 10.1093/infdis/jiab229.
PMID: 34009371
responsible party type: Sponsor
mesh term: HIV Infections
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 